Systems and methods for medical device control

ABSTRACT

Systems, devices, and methods of the present disclosure assist with management of tubes and hoses during surgical procedures. The systems, devices, and methods provide for the proper opening and closing of tubes to facilitate performance of steps in a surgical procedure. Systems, devices, and methods of the present disclosure control fluid delivery to and from a medical device, including devices for tissue processing and cleaning.

This application claims priority to U.S. Provisional Patent Application62/381,118, which was filed on Aug. 30, 2016 and which is incorporatedherein by reference in its entirety.

The present application relates to systems and methods for control offluid delivery to and from a medical device, including devices fortissue processing and cleaning.

Some surgical procedures require use of tubes, hoses, or other conduitsto transfer fluids, gases, and/or tissue products between a patient anda treatment system or device, or among systems and devices. Somesurgical procedures are multi-step processes requiring connection anddisconnection of hoses from input and output ports. For example, usingsome adipose tissue transfer systems, surgical personnel may need toperform over one hundred combined user actions and decisions. Some ofthese user actions involve enabling and disabling a vacuum source oradding or removing tissue or washing solutions to a tissue storage andtreatment container.

Keeping track of the state of tube connections in some surgicalprocedures creates a burden on the practitioner. The user effort neededto manage the tube connections is not negligible and can increase thetotal time to perform procedures. Although organizational technologiessuch as color-coding exist, they cannot eliminate the burden of needingto assess the state of each individual tube at multiple pointsthroughout a procedure.

In an embodiment of the present invention, a tissue treatment systemincludes a container and a flow management device. The containerincludes an exterior wall surrounding an interior volume for holdingtissue. The container also includes a filter structure for processingtissue. The flow management device includes a first plate having aplurality of first openings passing therethrough. The flow managementdevice also includes a second plate having a plurality of secondopenings passing therethrough. The flow management device also includesa third plate having one or more third openings passing therethrough.The first plate, second plate, and third plate are operably connected.Setting the third plate in a first position places a first subset of theplurality of first openings in fluid communication with a first subsetof the plurality of second openings. Setting the third plate in a secondposition places a second subset of the plurality of first openings influid communication with a second subset of the plurality of secondopenings. Setting the third plate to a third position places a thirdsubset of the plurality of first openings in fluid communication with athird subset of the plurality of second openings.

In an embodiment of the present invention, a flow management deviceincludes a first plate having a plurality of first openings passingtherethrough. The flow management device also includes a second platehaving a plurality of second openings passing therethrough. The flowmanagement device also includes a third plate having one or more thirdopenings passing therethrough. The first plate, second plate, and thirdplate are operably connected. Setting the third plate in a firstposition places a first subset of the plurality of first openings influid communication with a first subset of the plurality of secondopenings. Setting the third plate in a second position places a secondsubset of the plurality of first openings in fluid communication with asecond subset of the plurality of second openings. Setting the thirdplate to a third position places a third subset of the plurality offirst openings in fluid communication with a third subset of theplurality of second openings.

In an embodiment of the present invention, a tissue treatment systemincludes a container and a tube management device. The containerincludes an exterior wall surrounding an interior volume for holdingtissue and a filter structure for processing tissue. The tube managementdevice includes a tube restrictor plate having a plurality of tubethrough-holes and a tube stabilizer plate having a plurality of tubethrough-holes. A plurality of flow-restricting devices is disposed onthe tube restrictor plate adjacent to the plurality of tubethrough-holes. The tube management device further includes amulti-position switch. A plurality of tubes passes through the tubethrough-holes. Moreover, setting the multi-position switch to a firstposition causes the plurality of flow-restricting devices to restrictthe flow in a first subset of the plurality of tubes to transfer tissuefrom a patient to the interior volume, setting the multi-position switchto a second position causes the plurality of flow-restricting devices torestrict the flow in a second subset of the plurality of tubes to allowprocessing of the tissue in the interior volume, and setting themulti-position switch to a third position causes the plurality offlow-restricting devices to restrict the flow in a third subset of theplurality of tubes to allow transfer of the tissue out of the interiorvolume.

In an embodiment of the present invention, a method of managing surgicalconduits is described. The method includes providing a plurality oftubes and a plurality of flow-restricting devices within a device body,each of the flow-restricting devices proximal to at least one of theplurality of tubes. The method also includes providing a multi-positionswitch wherein flow in a first subset of the plurality of tubes isrestricted by the plurality of flow-restricting devices when themulti-position switch is in a first position and flow in a second subsetof the plurality of tubes different than the first subset is restrictedby the plurality of flow-restricting devices when the multi-positionswitch is in a second position. The method also includes switching fromthe first position of the multi-position switch to the second positionof the multi-position switch.

In an embodiment of the present invention, a tube management deviceincludes a tube restrictor plate having a plurality of tubethrough-holes and a tube stabilizer plate having a plurality of tubethrough-holes. A plurality of flow-restricting devices is disposed onthe tube restrictor plate adjacent to the plurality of tubethrough-holes. The tube management device also includes a multi-positionswitch and a plurality of tubes that pass through the plurality of tubethrough-holes. Setting the multi-position switch of the tube managementdevice to a first position causes the plurality of flow-restrictingdevices to restrict the flow in a first subset of the plurality oftubes, setting the multi-position switch to a second position causes theplurality of flow-restricting devices to restrict the flow in a secondsubset of the plurality of tubes, and setting the multi-position switchto a third position causes the plurality of flow-restricting devices torestrict the flow in a third subset of the plurality of tubes.

In an embodiment of the present invention, a tissue treatment systemincludes a container and a flow management device. The containerincludes an exterior wall surrounding an interior volume for holdingtissue. The container also includes a filter structure for processingtissue. The flow management device includes a first plate having aplurality of first openings passing therethrough. The flow managementdevice also includes a second plate having a plurality of secondopenings passing therethrough. The first plate and the second plate areoperably connected. Setting the first plate in a first position places afirst subset of the plurality of first openings in fluid communicationwith a first subset of the plurality of second openings. Setting thefirst plate in a second position places a second subset of the pluralityof first openings in fluid communication with a second subset of theplurality of second openings. Setting the first plate to a thirdposition places a third subset of the plurality of first openings influid communication with a third subset of the plurality of secondopenings.

In an embodiment of the present invention, a flow management deviceincludes a first plate having a plurality of first openings passingtherethrough. The flow management device also includes a second platehaving a plurality of second openings passing therethrough. The firstplate and the second plate are operably connected. Setting the firstplate in a first position places a first subset of the plurality offirst openings in fluid communication with a first subset of theplurality of second openings. Setting the first plate in a secondposition places a second subset of the plurality of first openings influid communication with a second subset of the plurality of secondopenings. Setting the first plate to a third position places a thirdsubset of the plurality of first openings in fluid communication with athird subset of the plurality of second openings.

In an embodiment of the present invention, a flow management deviceincludes a body including a plurality of first openings and a pluralityof second openings. The flow management device also includes amulti-position switch. The flow management device also includes aspindle within the body and coupled to the multi-position switch, thespindle including a plurality of third openings. Setting themulti-position switch to a first position places a first subset of theplurality of first openings in fluid communication with a first subsetof the plurality of second openings via a first subset of the pluralityof third openings. Setting the multi-position switch to a secondposition places a second subset of the plurality of first openings influid communication with a second subset of the plurality of secondopenings via a second subset of the plurality of third openings. Settingthe multi-position switch to a third position places a third subset ofthe plurality of first openings in fluid communication with a thirdsubset of the plurality of second openings via a third subset of theplurality of third openings.

In an embodiment of the present invention, a flow management deviceincludes a plurality of diaphragm units. Each diaphragm unit includes aflexible diaphragm, a first opening, and a second opening. The diaphragmunits have an open position wherein the first opening and second openingare in fluid communication and a closed position wherein the firstopening and the second opening are not in fluid communication. The flowmanagement device also includes a rotating plate including one or moreprotrusions. Each protrusion is capable of pressing against the flexiblediaphragm of a diaphragm unit to place the diaphragm unit in the closedposition. Rotating the rotating plate to a first position places a firstsubset of the diaphragm units into the closed position. Rotating therotating plate to a second position places a second subset of thediaphragm units into the closed position. Rotating the rotating plate toa third position places a third subset of the diaphragm units into theclosed position.

In an embodiment of the present invention, a tissue treatment deviceincludes a container. The container includes an exterior wallsurrounding an interior volume for holding tissue and a filter structurefor processing tissue.

In an embodiment of the present invention, a tissue treatment systemincludes a container and a flow management device. The containerincludes an exterior wall surrounding an interior volume for holdingtissue and a filter structure for processing tissue. The flow managementdevice includes a first barrier wall having a plurality of firstopenings passing therethrough. The flow management device includes asecond barrier wall having a plurality of second openings passingtherethrough. The flow management device includes a third barrier wallhaving one or more third openings passing therethrough. The firstbarrier wall, second barrier wall, and third barrier wall are operablyconnected. Setting the third barrier wall in a first position places afirst subset of the plurality of first openings in fluid communicationwith a first subset of the plurality of second openings. Setting thethird barrier wall in a second position places a second subset of theplurality of first openings in fluid communication with a second subsetof the plurality of second openings. Setting the third barrier wall in athird position places a third subset of the plurality of first openingsin fluid communication with a third subset of the plurality of secondopenings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a tissue treatment system according to variousembodiments;

FIG. 2 is an exploded view of a tube management device according tovarious embodiments;

FIG. 3 is a top view of one embodiment of a tube restrictor plate and atube stabilizer plate, which are components of a tube management systemaccording to the present invention;

FIG. 4 illustrates a decision matrix for determining the status ofassorted system inputs in an exemplary tissue transfer system, asdescribed in various embodiments;

FIG. 5 is an exploded view of an alternative tube management deviceaccording to the present invention;

FIG. 6 illustrates a variant of the tube management device displayed inFIG. 5, according to various embodiments;

FIG. 7 is a top view of a tube restrictor plate and a tube stabilizerplate of the tube management device of the embodiment shown in FIG. 6;

FIG. 8 illustrates a tube management device according to variousembodiments.

FIG. 9A illustrates a tissue processing device including a flowmanagement device in accordance with various embodiments of the presentdisclosure.

FIG. 9B illustrates a cutaway view of the flow management device of FIG.9A in accordance with various embodiments of the present disclosure.

FIG. 9C illustrates a partial view of a component of the flow managementdevice shown in FIG. 9B in accordance with some embodiments of thepresent disclosure.

FIG. 9D illustrates a side cross-sectional view of the flow managementdevice of FIG. 9B in accordance with some embodiments of the presentdisclosure.

FIGS. 10A and 10B illustrate cross-sectional views of portions of flowmanagement devices in accordance with various embodiments of the presentdisclosure.

FIG. 11A illustrates a cutaway view of a tissue treatment systemincluding an integrated flow management device in accordance withvarious embodiments of the present disclosure.

FIG. 11B illustrates an exploded view of the tissue treatment system ofFIG. 11A.

FIG. 12A illustrates a cutaway view of a tissue treatment systemincluding a flow management device subassembly in accordance withvarious embodiments of the present disclosure.

FIG. 12B illustrates an exploded view of the tissue treatment system ofFIG. 12A.

FIG. 13A illustrates a flow management device including a spindle inaccordance with various embodiments of the present disclosure.

FIG. 13B illustrates a cross-sectional view of the flow managementdevice shown in FIG. 13A.

FIG. 14A illustrates a cross-sectional view of a flow management deviceincluding a diaphragm valve in an open position in accordance withvarious embodiments of the present disclosure.

FIG. 14B illustrates a cross-sectional view of the flow managementdevice including a diaphragm valve in a closed position in accordancewith various embodiments of the present disclosure.

FIG. 15A illustrates a tissue treatment system including a turbine inaccordance with various embodiments of the present disclosure.

FIG. 15B illustrates a magnified view of a portion of the system of FIG.15A showing the connection between the turbine and a mount for mixingblades in accordance with various embodiments of the present disclosure.

FIG. 15C illustrates a cutaway view of the turbine incorporated into thesystem of FIG. 15A in accordance with various embodiments of the presentdisclosure.

FIG. 15D illustrates engagement of a turbine with a mixing shaft througha gear system in accordance with various embodiments of the presentdisclosure.

FIG. 16 illustrates a tissue treatment system including a volumemeasurement device in accordance with various embodiments of the presentdisclosure.

FIGS. 17A and 17B illustrate various mesh filters for use in tissuetreatment systems according to various embodiments of the presentdisclosure.

FIG. 17C illustrates a straight-walled mesh filter according to variousembodiments of the present disclosure.

FIGS. 18A and 18B illustrate a disassembled and assembled filteringstructure, respectively, according to various embodiments of the presentdisclosure.

FIG. 18C illustrates a tissue treatment system including a filteringstructure.

FIG. 19A illustrates an exploded view of a conical mesh filter for usein tissue treatment systems according to various embodiments of thepresent disclosure.

FIG. 19B illustrates placement of the filter of FIG. 19A in a tissuetreatment system according to various embodiments of the presentdisclosure.

FIG. 19C illustrates a cross-sectional view of a filtering structureaccording to various embodiments of the present disclosure.

FIG. 19D illustrates a pre-form for a filtering structure according tovarious embodiments of the present disclosure.

FIG. 19E illustrates a filtering structure, according to variousembodiments of the present disclosure.

FIGS. 20A and 20B illustrate two configurations of telescoping mixingpaddles for use in tissue treatment systems according to variousembodiments of the present disclosure.

FIGS. 20C and 20D illustrate tissue treatment systems with telescopingmixing paddles in accordance with various embodiments.

FIGS. 21A-21D illustrate telescoping mixing paddles for use in tissuetreatment systems according to various embodiments of the presentdisclosure.

FIGS. 22A and 22B illustrate a tissue treatment system including amixing device with a disc portion that can be opened or closed for useas an ejection piston in accordance with various embodiments of thepresent disclosure.

FIG. 23 illustrates a tissue treatment system with a mixing and augersystem to facilitate tissue extraction in accordance with variousembodiments of the present disclosure.

FIGS. 24A and 24B illustrate perspective and top views of the mixing andauger system of FIG. 23 in a tissue treatment system in accordance withvarious embodiments of the present disclosure.

FIGS. 25A and 25B illustrate alternative embodiments of mixing and augersystems to facilitate tissue extraction in accordance with variousembodiments of the present disclosure.

FIGS. 26A and 26B illustrate alternative embodiments of motorized tissuetreatment systems in accordance with various embodiments of the presentdisclosure

FIG. 27A illustrates a transparent open view of the motorized system toagitate tissue shown in FIG. 26B in accordance with various embodimentsof the present disclosure.

FIG. 27B illustrates a perspective view of a motorized tissue treatmentdevice in accordance with various embodiments of the present disclosure.

FIG. 27C illustrates a top view of a motorized tissue treatment devicein accordance with various embodiments of the present disclosure.

FIGS. 28A and 28B illustrate a tissue treatment system including asterile drape in accordance with various embodiments of the presentdisclosure.

FIGS. 29A-29D illustrate a tissue treatment system including a base anda replaceable tissue processing unit in accordance with variousembodiments of the present disclosure.

FIGS. 30A and 30B illustrate a tissue treatment system including a tubemanagement device during various phases of operation in accordance withvarious embodiments of the present disclosure.

FIGS. 31A-31D illustrate views of a tissue treatment system and acorresponding tube management device in accordance with variousembodiments of the present disclosure.

FIG. 32 illustrates an inferior perspective view of the tissue treatmentsystem of FIG. 31A.

FIGS. 33A-33D illustrate views of a tissue treatment system including atube management device in accordance with various embodiments of thepresent disclosure.

FIG. 34 illustrates a tissue treatment system including a tubemanagement device in accordance with various embodiments of the presentdisclosure.

FIG. 35 illustrates a tissue treatment system including a hollow centralshaft to extract adipose tissue in accordance with various embodimentsof the present disclosure.

FIG. 36 illustrates an alternative embodiment of a tissue treatmentsystem including a hollow central shaft in accordance with variousembodiments of the present disclosure.

FIG. 37A illustrates a low profile tissue treatment system in accordancewith various embodiments of the present disclosure.

FIG. 37B is a side view of the system of FIG. 37A.

FIG. 38 illustrates a tissue treatment system in accordance with variousembodiments of the present disclosure.

FIG. 39A illustrates a perspective view of a tissue treatment systemincluding a molded handle in accordance with various embodiments of thepresent disclosure.

FIG. 39B illustrates a side view of a tissue treatment system includinga molded handle in accordance with various embodiments of the presentdisclosure.

FIG. 40 illustrates a tissue treatment system including multiple moldedhandles in accordance with various embodiments of the presentdisclosure.

FIGS. 41A-41C illustrate a tissue treatment system and associatedpackaging in accordance with various embodiments of the presentdisclosure.

FIGS. 42A and 42B illustrate a mounting system and a tissue treatmentsystem including the mounting system in accordance with variousembodiments of the present disclosure.

FIG. 43 illustrates a tissue treatment system including a mountingsystem in accordance with various embodiments of the present disclosure.

FIGS. 44A and 44B illustrate a tissue treatment system including astorage system for fluid(s) in accordance with various embodiments ofthe present disclosure.

FIGS. 45A and 45B illustrate a tissue treatment system including astorage system for fluid(s) in accordance with various embodiments ofthe present disclosure.

FIGS. 46A and 46B illustrate perspective and side views, respectively,of a tissue treatment system including a tube management device inaccordance with various embodiments of the present disclosure.

FIG. 47 illustrates a tissue treatment system with a wash cycle counterin accordance with various embodiments of the present disclosure.

FIGS. 48A and 48B illustrate a collapsible tissue treatment system inuncollapsed and collapsed states, respectively, in accordance withvarious embodiments of the present disclosure.

FIGS. 49A-49C illustrate a tissue treatment system in accordance withvarious embodiments of the present disclosure.

FIG. 50 illustrates a tissue treatment system in accordance with variousembodiments of the present disclosure.

FIGS. 51A-51C illustrate views of a tissue treatment system inaccordance with various embodiments of the present disclosure.

FIGS. 52A-52C illustrate views of a tissue treatment system inaccordance with various embodiments of the present disclosure.

FIGS. 53A-53C illustrate views of a tissue treatment system inaccordance with various embodiments of the present disclosure.

FIG. 54A-54E illustrate views of a tissue treatment system in accordancewith various embodiments of the present disclosure.

DESCRIPTION OF EXEMPLARY EMBODIMENTS

Reference will now be made in detail to certain exemplary embodimentsaccording to the present disclosure, certain examples of which areillustrated in the accompanying drawings. Wherever possible, the samereference numbers will be used throughout the drawings to refer to thesame or like parts.

In this application, the use of the singular includes the plural unlessspecifically stated otherwise. In this application, the use of “or”means “and/or” unless stated otherwise. Furthermore, the use of the term“including,” as well as other forms such as “included” and “includes,”is not limiting. The section headings used herein are for organizationalpurposes only and are not to be construed as limiting the subject matterdescribed. All documents, or portions of documents, cited in thisapplication including but not limited to patents, patent applications,articles, books, and treatises are hereby expressly incorporated byreference in their entirety for any purpose.

As used herein, “adipose tissue” refers to adipose tissue obtained byany means including, for example, liposuction and/or tumescentliposuction. In addition, the adipose tissue may be substantially intactor may be altered by, for example, washing with saline, antimicrobials,detergents, or other agents; the addition of therapeutic agents such ananalgesics, antimicrobials, and anti-inflammatories; the removal of somecells or acellular components; or disruption or alteration by thecollection process itself including, for example, during liposuction ortumescent liposuction. The adipose tissue can be autologous tissue,allogeneic tissue, or xenogenic tissue (e.g., porcine tissue).

As described above, some surgical procedures require use of tubes,hoses, or other conduits to transfer fluids, gases, and/or tissueproducts between a patient and a treatment system or device, or amongsystems and devices. Multi-step procedures are not uncommon and mayrequire connection and disconnection of hoses from input and outputports. For example, a system for adipose tissue transfer and processing(e.g., adipose washing) can require over one hundred combined useractions and decisions, including enabling and disabling vacuum sourcesor adding or removing tissue or washing solutions to a tissue storageand treatment container. The maintenance and verification of tubeconnections during a surgical or medical procedure can be non-trivial,especially when the procedure has a time-sensitive component.

Various human and animal tissues can be used to produce products fortreating patients. For example, various tissue products have beenproduced for regeneration, repair, augmentation, reinforcement, and/ortreatment of human tissues that have been damaged or lost due to variousdiseases and/or structural damage (e.g., from trauma, surgery, atrophy,and/or long-term wear and degeneration). Fat grafting, includingautologous fat grafting, can be useful for a variety of clinicalapplications including facial fillers, breast augmentation, buttockaugmentation/sculpting, augmentation of other tissue sites, correctionof lumpectomy defects, cranial-facial defect correction, and correctionof lipoplasty defects (e.g., divots).

To prepare tissue for autologous fat grafting, tissue cleaning andprocessing must be performed. The process of grafting typically involvessteps such as removal of tissue from a patient with a syringe orcannula. The removed tissue is pulled into a tissue processing containerwhere unwanted components of the tissue (or additives to the tissue) canbe separated and/or the tissue can be cleaned using various solutions. Atypical system might include meshes for filtration and separation,cranks connected to mixing blades, and several input and output ports(e.g., to add or remove processing fluids and to transfer tissue). Oncethe tissue is sufficiently prepared, it must be removed from thecontainer and injected or grafted back into the patient. During transfersteps, vacuum devices help move the tissue from location to location.However, it is desirable to disconnect the vacuum pressure duringprocessing steps. In addition, the tubes that are not in use during anygiven step should be blocked to maintain the sterility of the system orallow application of suction or movement through appropriate tubes.

Turning to FIG. 1, an illustrative embodiment of a tissue treatmentsystem 100 is shown. As shown, the tissue treatment system 100 caninclude a container having an exterior wall 110 surrounding an interiorvolume. The interior of the container can also contain filters, mixingblades, hoses, and other components to enable washing and conditioningof tissue. The system 100 can include a tube management device 101 tofacilitate operation of the system 100. Tubes can pass from the exteriorof the system 100 to the interior through ports 102 of the tubemanagement device 101, and tube restrictor devices (discussed below)within the tube management device 101 can control which tubes are openand which are blocked for a given system configuration. The systemconfiguration is determined by the setting of a multi-position switch103. In some embodiments, the system 100 can be provided with a carryhandle for convenient handling by a user. In some embodiments, the tubemanagement device 101 can hold a blocked tube against at least 1atmosphere (i.e., about 75 cmHg) of vacuum without leaking.

As used herein, the terms “tube,” “hose,” “conduit,” or similar languagewill be used interchangeably and will be understood to refer to anypassageway having a lumen configured to allow passage or fluids, gases,and/or tissue products therethrough.

An exploded view of one embodiment of a tube management device 101 isshown in FIG. 2. The tube management device 101 may include ports 102 a,102 b, 102 c and a multi-position switch 103. Tubes can pass through theports 102 a, 102 b, 102 c and then through a tube restrictor plate 104and a tube stabilizer plate 107 before passing out of the device 101.Based on the position of the multi-position switch 103, restrictorelements 105 on the tube restrictor plate 104 can allow or obstruct flowthrough each of the tubes. In some embodiments, the contents of the tubemanagement device 101 can be contained within an exterior wall 108 thatforms a body. In alternate embodiments, the components of the tubemanagement device 101 can be attached directly to the structure of thecontainer 110.

The ports 102 a, 102 b, 102 c can have a variety of configurations. Inaccordance with various embodiments, the ports 102 a, 102 b, 102 c maybe straight-walled or barbed; threaded or unthreaded; and have nofittings, luer fittings, swaged fittings, or any other type of connectorsuitable for a specific application. Although the ports 102 a, 102 b,102 c are depicted as extending out from the body of the tube managementdevice 101, the ports may also be threaded or unthreaded holes orrecesses or may extend inward from the surface into the body of thedevice 101. Although only three ports are depicted in FIG. 2, any numberof ports can be chosen to match the number of tubes needed in aparticular application. Substances including, but not limited to, gases,liquids, chemical solutions, and biological tissues can flow into or outfrom the ports 102 a, 102 b, 102 c depending upon the position of themulti-position switch and the requirements of any particular step of themedical procedure.

The position of the multi-position switch 103 can be used to switchamong different device configurations. In some embodiments, themulti-position switch 103 is a rotating body or knob, and the rotationalangle of the body determines the switch state. In accordance withvarious embodiments, the multi-position switch 103 may be any mechanicalor electronic switch (including rotational or linear throw switches)that, through appropriate linkages, can alter the state of openness oftubes passing through the device. In some embodiments, themulti-position switch 103 can include non-slip grips or similar featuresto facilitate easier operation by a user, in particular by a userwearing surgical gloves. The positions of the multi-position switch 103may correspond to steps in a procedure. For example, the steps in aprocedure might include liposuction/tissue extraction, hold and mix,irrigation, and vacuum/clear steps.

The tube restrictor plate 104 can block or allow flow through tubes thatpass through the tube through-holes of the plate 104 through the use offlow-restricting devices. In accordance with various embodiments, and asdepicted in FIGS. 2 and 3, the tube restrictor plate 104 may be providedwith flow-restricting devices 105 in the form of contoured radial slots.The slots 105 can have a slot width that varies according to the desiredaction of the slot upon a tube for each angular position of the tuberestrictor plate 104. For example, each slot 105 may include two slotwidths that correspond to either unrestricted flow in a tube or completeblockage of flow in a tube. Alternatively, each slot may have a range ofwidths corresponding to different levels of flow restriction. In someembodiments, the tube restrictor plate 104 can comprise an acrylicmaterial.

In FIG. 3, a tube restrictor plate 104 is shown overlaid upon a tubestabilizer plate 107 with slots 105 a, 105 b, 105 c indicated. Theexample embodiment of a tube restrictor plate 104 shown in FIG. 3illustrates tube through-holes in the form of contoured radial slots 105a, 105 b, 105 c suitable for a tube management device 101 having amulti-position switch 103 with three positions. The contoured radialslots 105 a, 105 b, 105 c of the tube restrictor plate 104 are overlaidin this top view on the tube through-holes 115 a, 115 b, 115 c of thetube stabilizer plate 107. In this figure, the position of tuberestrictor plate 104 with respect to tube stabilizer plate 107 placesslots 105 a, 105 b, 105 c in the first position over tube through-holes115 a, 115 b, 115 c. Activation of the multi-position switch 103 cancause the tube restrictor plate 104 to rotate in the direction shown bythe arrow while the tube stabilizer plate 107 stays in place. As aresult, the radial slots can advance to the second or third position asneeded. In one embodiment, activation of the multi-position switch 103can cause the tube stabilizer plate 107 to rotate while the tuberestrictor plate 104 stays in place. In accordance with variousembodiments, the system 100 can be provided with a plurality of tuberestrictor plates 104 having different arrangements of slots 105 a, 105b, 105 c intended for different procedures having different steps. Inthese embodiments, the user may choose one of the plurality of tuberestrictor plates 104 to place within the body 108 of the device 101depending upon the application.

The tube restrictor plate 104 may have locating features 106 that caninterlock with the multi-position switch 103. The locating features 106can help the user align the tube restrictor plate with themulti-position switch 103 and within the tube management device 101 sothat the contoured radial slots 105 a, 105 b, 105 c are properly in-linewith their respective ports 102 a, 102 b, 102 c. In addition, thelocating features 106 can match with complementary features on themulti-position switch so that the switch's position reflects the propertubing state within the tube management device 101. In some embodiments,the locating features 106 can fix the multi-position switch 103 to thetube restrictor plate 104 such that they move in concert when the switchis rotated.

The tube management device 101 can have a tube stabilizer plate 107. Thetube stabilizer plate 107 may have tube through-holes 115 to allow tubesto pass therethrough. In some embodiments, the diameter of each of thetube through-holes 115 in the tube stabilizer plate 107 may be equal orapproximately equal to the outer diameter of the corresponding tube thatpasses through the hole 115 to provide a secure fit around the outsideof each tube without compression. The tube stabilizer plate 107 can holdthe tube in position so that activation or movement of the tuberestrictor plate 104 cannot twist, reorient, or move the tubes.

As discussed above, the system 100 can be used to operate surgicalsystems, such as adipose tissue transfer systems. Accordingly, anexemplary decision matrix 400 for an adipose tissue transfer process isshown in FIG. 4. The decision matrix may be used to determine theopen/closed status of any tubes in the system during any steps of anadipose transfer procedure. In some embodiments, a tissue treatmentsystem 100 similar to that shown in FIG. 1 can have 4 tube inputs thatare either open or blocked during a given step of a medical procedure.In a liposuction or aspiration 402 step, the tube to the liposuctioncannula and the vacuum tube may be open while the irrigation tube andvent tube are closed. In a hold and mix or washing 404 step, all 4inputs can be blocked. In an irrigation or transfer 406 step, the tubeto the liposuction cannula and the vacuum tube may be closed while theirrigation tube and the vent tube can be open. In a vacuum/clear 408step, the tube to the liposuction cannula and the irrigation tube may beclosed while the vacuum tube and the vent tube can be open.

Accordingly, and consistent with the decision matrix or foreseeablevariations thereof depending on the particular tissue processing beingperformed, methods of processing adipose tissue are provided. Themethods can include at least the following steps, which can beimplemented using the various devices described herein and illustratedin any of the disclosed figures. The method can include a first stepwherein the device, via a multi-position switch (see, e.g., handle 903or switch 1003), is set for a liposuction mode, opening a tissuetransfer input port and a vacuum port. The method can include a secondstep, for processing tissue, wherein the switch may be set to a mode forholding and processing (e.g., mixing or incubating) tissue, with allports likely being closed. The method can further include a third stepfor irrigation, wherein the multi-position switch is set to allowopening of one or more irrigation or fluid input ports; and a fourthstep, for vacuuming (e.g., to remove irrigation or fluid).

It will be appreciated, however, that the various steps may be modified,and/or repeated. For example, multiple irrigation and vacuum/cleaningsteps may be performed, and additional ports can be included, asdiscussed herein.

An alternate embodiment of a tube management device 501 is shown in FIG.5. The tube management device 501 can include ports 502 and amulti-position switch 503. Tubes can pass from the ports 502 through atube restrictor plate 504 and a tube stabilizer plate 507 before passingout of the device 501. Based on the position of the multi-positionswitch, restrictor elements 505 on the tube restrictor plate 504 canallow or obstruct flow through each of the tubes. The contents of thetube management device 501 can be contained within an exterior wall 508that forms a body.

As with the previously discussed embodiments, the ports can have avariety of configurations. For example, the ports 502 may bestraight-walled or barbed; threaded or unthreaded; and have no fittings,luer fittings, swaged fittings, or any other type of connector demandedby application-specific requirements. Although the ports 502 aredepicted in this embodiment as extending out from the body of the tubemanagement device 501, the ports may also be threaded or unthreadedrecesses or holes or may extend inward from the device surface into thebody of the device 501. Although only three ports are depicted in FIG.5, any number of ports can be chosen to match the number of tubes neededin a particular application. Substances including, but not limited to,gases, liquids, chemical solutions, and biological tissues can flow intoor out from the ports 502 depending upon the position of themulti-position switch and the requirements of any particular step of thesurgical procedure.

The positions of the multi-position switch 503 can be used to switchamong different device configurations. In some embodiments, themulti-position switch 503 is a rotating body or knob and the rotationalangle of the body determines the switch state. In accordance withvarious embodiments, the multi-position switch 503 may be any mechanicalor electronic switch (including rotational or linear throw switches)that, through appropriate linkages, can alter the state of openness oftubes passing through the device. In some embodiments, themulti-position switch 503 can include non-slip grips or similar featuresto facilitate easier operation by a user, in particular by a userwearing surgical gloves. The positions of the multi-position switch 503may correspond to steps in a procedure. For example, the steps in aprocedure might include liposuction/tissue extraction, hold and mix,irrigation, and vacuum/clear steps.

The tube restrictor plate 504 can block or allow flow through the tubesthat pass through the tube through-holes 516 of the plate through theuse of flow-restricting devices. The tube restrictor plate 504 mayinclude an external ring 504 a that is rotatably engaged with a centralportion 504 b. Tubes can pass through the tube restrictor plate 504through tube through-holes 516 adjacent to flow-restricting devices. Inaccordance with various embodiments and as depicted in FIG. 5, the tuberestrictor plate 504 may be provided with flow-restricting devices inthe form of a contoured central hub 512 on the central portion 504 b andsliding blocks 505 that force the tubes against the hub 512 via theintegrated springs 514 attached to the external ring 504 a. The slidingblocks 505 may be shaped as flat plates, cylinders, ovals, spheres,ovoid configuration, or any other shape that meets application-specificrequirements. In some embodiments, the contoured central hub 512 mayhave an equal number of recesses to the number of ports 502, and eachtube may pass through a tube through-hole 516 adjacent to a recess ofthe contoured central hub. When a sliding block 505 attached to anintegrated spring 512 is in line with a recess of the contoured centralhub 512, the force of the spring may extend the sliding block and forceit against a tube. In some embodiments, the central portion 504 b of thetube restrictor plate 504 may be fixedly attached to the tube stabilizerplate 507. As the multi-position switch 503 changes from one position toanother, the external ring 504 a of the tube restriction plate 504 mayrotate while the central portion 504 b containing the contoured centralhub 512 does not rotate relative to the tube stabilizer plate 507.

In accordance with various embodiments, the external ring 504 a may beprovided with a one-way ratcheting mechanism 509. The teeth of theratcheting mechanism can engage with a pawl 511 positioned on thecentral portion 504 b of the tube restriction plate 504 such thatrotation of the external ring 504 a is allowed in one direction butprevented in the opposite direction. Although the pawl 511 is depictedas being located on the central portion 504 b in this embodiment, itwill be apparent to those of ordinary skill in the art that the pawlcould be attached at other points throughout the tube management device501 such as the interior of the multi-position switch 503 or the tubestabilizer plate 507.

The tube management device 501 can also include a tube stabilizer plate507. The tube stabilizer plate 507 may have tube through-holes 515 toallow tubes to pass through. In some embodiments, the diameter of eachof the tube through-holes 515 in the tube stabilizer plate 507 may beequal to or slightly greater than the outer diameter of thecorresponding tube that passes through the hole to provide a secure fitaround the outside of each tube without compression. The tube stabilizerplate 507 can hold the tube in position so that activation or movementof the tube restrictor plate 504 cannot twist, reorient, or move thetubes.

Another embodiment of a tube management device is shown in FIG. 6. Thetube management device 601 can include ports 602 and a multi-positionswitch 603. The device 601 can include a tube stabilizer plate 607 and atube restrictor plate 604 containing flow restriction devices. Thecomponents of the device 601 can be enclosed within a body 608.

The ports 602 are the connection between the tube management device 601and the exterior world. In accordance with various embodiments, theports 602 may be straight-walled or barbed; threaded or unthreaded; andhave no fittings, luer fittings, swaged fittings, or any other type ofconnector demanded by application-specific requirements. Although theports 602 are depicted in this embodiment as extending out from the bodyof the tube management device 601, the ports may also be threaded orunthreaded holes or may extend inward from the device surface into thebody of the device 601. Although only three ports are depicted in FIG.6, it will be evident to one of ordinary skill in the art that anynumber of ports 602 can be chosen to match the number of tubes needed ina particular application. Fluids including, but not limited to, gases,liquids, chemical solutions, and biological tissues can flow into or outfrom the ports 602 depending upon the position of the multi-positionswitch and the requirements of any particular step of the medicalprocedure.

The positions of the multi-position switch 603 can be used to switchamong different device configurations. In some embodiments, themulti-position switch 603 is a rotating body or knob and the rotationalangle of the body determines the switch state. In accordance withvarious embodiments, the multi-position switch 603 may be any mechanicalor electronic switch (including rotational or linear throw switches)that, through appropriate linkages, can alter the state of openness oftubes passing through the device. In some embodiments, themulti-position switch 603 can include non-slip grips or similar featuresto facilitate easier operation by a user, in particular by a userwearing surgical gloves. The positions of the multi-position switch 603may correspond to steps in a procedure. For example, the steps in aprocedure might include liposuction/tissue extraction, hold and mix,irrigation, and vacuum/clear steps.

The tube restrictor plate 604 may include an external ring 604 a that isrotatably engaged with a central portion 604 b. Tubes may pass throughtube through-holes 616 adjacent to flow-restricting devices. Inaccordance with various embodiments and as depicted in FIG. 6, the tuberestrictor plate 604 may be provided with flow-restricting devices inthe form of a contoured central hub 612 on the central portion 604 b andsliding blocks 605 that force the tubes against the hub 612 via theintegrated springs 614 attached to the external ring 604 a. The slidingblocks 605 may be shaped as flat plates, cylinders, ovals, spheres,eggs, or any other shape that meets application-specific requirements.In some embodiments, the contoured central hub 612 may have an equalnumber of recesses to the number of ports 602, and each tube may passthrough a tube through-hole 616 adjacent to a recess of the contouredcentral hub. When a sliding block 605 attached to an integrated spring612 is in line with a recess of the contoured central hub 612, the forceof the spring may extend the sliding block and force it against a tube.As the multi-position switch 603 changes from one position to another,the external ring 604 a of the tube restriction plate 604 may rotatewhile the central portion 604 b containing the contoured central hub 612does not rotate relative to the tube stabilizer plate 607. In accordancewith various embodiments, the sliding blocks 605 and integrated springs614 can be placed at different radial depths using spacers 604 c.

The tube management device 601 can have a tube stabilizer plate 607 insome embodiments. The tube stabilizer plate 607 may have tubethrough-holes 615 to allow tubes to pass through. In preferredembodiments, the diameter of each of the tube through-holes 615 in thetube stabilizer plate 607 may be equal to the outer diameter of thecorresponding tube that passes through the hole to provide a secure fitaround the outside of each tube without compression. The tube stabilizerplate 607 can hold the tube in position so that activation or movementof the tube restrictor plate 604 cannot twist, reorient, or move thetubes.

A top view of the tube restrictor plate 604 overlaid on tube stabilizerplate 607 of the embodiment of FIG. 6 is shown in FIG. 7. In accordancewith various embodiments, the tube restrictor plate 604 can have slots613 to allow the tubes to change position with respect to the contouredcentral hub 612 of the central portion 604 b and the associatedflow-restricting devices. In this way, a single embodiment of the tuberestrictor plate 604 can be used in more than one configuration. When atube is in an “in” position, the tube passes near a recess of thecontoured central hub 612 and can be closed by sliding blocks 605attached to spacers 604 c extending from the external ring 604 a. When atube is in an “out” position, the tube passes near an extended portionof the contoured central hub 612. In this position, the tube can beclosed by sliding blocks 605 that are attached by integrated springs 614directly to the external ring 604 a. In a preferred embodiment, slidingblocks 605 attached directly to the external ring 604 a without spacers604 c cannot reach tubes adjacent to recesses of the contoured centralhub 612.

In accordance with various embodiments, the external ring 604 a may beprovided with a one-way ratcheting mechanism 609. The teeth of theratcheting mechanism can engage with a pawl 611 positioned on thecentral portion 604 b of the tube restriction plate 604 such thatrotation of the external ring 604 a is allowed in one direction butprevented in the opposite direction. Although the pawl 611 is depictedas being located on the central portion 604 b in this embodiment, itwill be apparent to those of ordinary skill in the art that the pawlcould be attached at other points throughout the tube management device601 such as the interior of the multi-position switch 603 or the tubestabilizer plate 607.

A method of managing surgical conduits is also envisioned by theinventors. The method includes providing several tubes and severalflow-restricting devices within a body where each of theflow-restricting devices is proximal to at least one of the tubes andproviding a multi-position switch wherein the flow in a first subset ofthe tubes is restricted by the flow-restricting devices when the switchis in a first position and flow in a second subset of tubes differentthan the first subset is restricted by the flow-restricting devices whenthe switch is in a second position. The method can further includeswitching from the first position of the multi-position switch to thesecond position.

The step of providing several tubes and several flow-restricting deviceswithin a body where each of the flow-restricting devices is proximal toat least one of the tubes may include, but is not limited to, passingtubes through ports 102 and past flow-restricting devices 105 in a tubemanagement device 101 as described above in connection with FIGS. 1-3.

The step of providing a multi-position switch wherein the flow in afirst subset of the tubes is restricted by the flow-restricting deviceswhen the switch is in a first position and flow in a second subset oftubes different than the first subset is restricted by theflow-restricting devices when the switch is in a second position mayinclude, but is not limited to, providing a multi-position switch 103 ina tube management device 101 as described above in connection with FIGS.1-3.

The step of switching from the first position of the multi-positionswitch to the second position may include, but is not limited to,switching a multi-position switch 103 from a first position to a secondposition as described above in connection with FIGS. 1 and 2.

An exploded view of an alternative embodiment of a tube managementdevice 801 is shown in FIG. 8. The tube management device 801 mayinclude ports 802 a, 802 b, 802 c and a multi-position switch 803. Tubes812 pass through the ports 802 a, 802 b, 802 c and then through a tuberestrictor plate 804 and a tube stabilizer plate 807 before passing outof the device 801. Based on the position of the multi-position switch803, restrictor elements 805 on the tube restrictor plate 804 can allowor obstruct flow through each of the tubes 812. In some embodiments, thecontents of the tube management device 801 can be contained within anexterior wall 808 that forms a body.

The ports 802 a, 802 b, 802 c can have a variety of configurations asdescribed previously with respect to FIG. 2. In accordance with variousembodiments, the ports 802 a, 802 b, 802 c may be straight-walled orbarbed; threaded or unthreaded; and have no fittings, luer fittings,swaged fittings, or any other type of connector suitable for a specificapplication. Although the ports 802 a, 802 b, 802 c are depicted asextending out from the body of the tube management device 801, the portsmay also be threaded or unthreaded holes or recesses or may extendinward from the surface into the body of the device 801. Although onlythree ports are depicted in FIG. 8, any number of ports can be chosen tomatch the number of tubes 812 needed in a particular application.Substances including, but not limited to, gases, liquids, chemicalsolutions, and biological tissues can flow into or out of tubes 812passing through the ports 802 a, 802 b, 802 c depending upon theposition of the multi-position switch and the requirements of anyparticular step of a medical procedure.

As described above with reference to FIG. 2, the position of themulti-position switch 803 can be used to switch among different deviceconfigurations. In some embodiments, the multi-position switch 803 is arotating body or knob, and the rotational angle of the body determinesthe switch state. In accordance with various embodiments, themulti-position switch 803 may be any mechanical or electronic switch(including rotational or linear throw switches) that, throughappropriate linkages, can alter the state of openness of the tubes 812.In some embodiments, the multi-position switch 803 can include non-slipgrips or similar features to facilitate easier operation by a user, inparticular by a user wearing surgical gloves. The positions of themulti-position switch 803 may correspond to steps in a procedure. Forexample, the steps in a procedure might include liposuction/tissueextraction, hold and mix, irrigation, and vacuum/clear steps.

The tube restrictor plate 804 can block or allow flow through the tubes812 as they pass through the plate through the use of flow-restrictingdevices Similar to the embodiments depicted in FIGS. 2 and 3, the tuberestrictor plate 804 may be provided with both flow-restricting devicesand tube through-holes in the form of contoured radial slots 805. Inalternative embodiments, the flow-restricting devices can be similar tothose described above with reference to the embodiments of FIGS. 5 and6. The slots 805 can have a slot width that varies according to thedesired action of the slot upon a tube 812 for each angular position ofthe tube restrictor plate 804. For example, each slot 805 may includetwo slot widths that correspond to unrestricted flow in a tube 812 andcomplete blockage of flow in a tube 812. Alternatively, each slot mayhave a range of widths corresponding to different levels of flowrestriction.

The tube restrictor plate 804 may have locating features 806 that caninterlock with the multi-position switch 803. The locating features 806can help the user align the tube restrictor plate 804 with themulti-position switch 803 and within the tube management device 801 sothat the contoured radial slots 805 are properly in-line with theirrespective ports 802 a, 802 b, 802 c. In addition, the locating features806 can match with complementary features on the multi-position switchso that the switch's position reflects the proper tubing state withinthe tube management device 801. In some embodiments, the locatingfeatures 806 can fix the multi-position switch 803 to the tuberestrictor plate 804 such that they move in concert when the switch isrotated.

The tube management device 801 can have a tube stabilizer plate 807. Thetube stabilizer plate 807 may have tube through-holes 815 to allow tubesto pass therethrough. In some embodiments, the diameter of each of thetube through-holes 815 in the tube stabilizer plate 807 may be equal orapproximately equal to the outer diameter of the corresponding tube thatpasses through the hole to provide a secure fit around the outside ofeach tube without compression. The tube stabilizer plate 807 can holdthe tube in position so that activation or movement of the tuberestrictor plate 804 cannot twist, reorient, or move the tubes.

The tubes 812 of tube management device 801 can be made of any materialthat meets application-specific requirements. The tubes 812 may be madeof, for example but not limited to, PVC, high-density polyethylene,nylon, latex, silicone, polyurethane, TYGON®, or any non-reactive tubingor hose. As depicted in FIG. 8, the tubes 812 may extend out of theports 802 a, 802 b, 802 c or may terminate within or below the ports 802a, 802 b, 802 c. The tubes 812 may be permanently attached to the tubemanagement device 801, for example, at the ports 802 a, 802 b, 802 c orbody 808, or the tubes 812 may be removable and/or replaceable. Inaccordance with various embodiments, the tubes 812 may be disposed ofafter each procedure and replaced with new tubes 812 to allow for reuseof tube management device 801 for multiple procedures.

The embodiments described above include tube management devices that areoperable to release or constrict flow within tubes depending upon theconfiguration of the device. In addition to tube management devices,flow management devices taught herein can allow or interrupt flowbetween a plurality of first openings and a plurality of secondopenings. The first and second openings can be connected to fluid portsor tubes to carry liquids, gases, or biological material. In someembodiments, the first openings and the second openings can be definedin stationary or movable walls, plates, or other barrier materials thatotherwise prevent the passage of liquids, gases, or biological material.In addition, the various embodiments can be combined and interchanged,e.g., using combinations of tube management devices described above andthe systems for controlling flow through various openings. Severalembodiments and implementations of flow management devices are describedbelow.

FIG. 9A illustrates a tissue processing device 900 including a flowmanagement device 901, a canister 918, and a stabilizing base 917. Theflow management device 901 can include ports 902 and a handle 903, whichcan serve as a multi-position switch. By moving the handle 903, a usercan allow, stop, or impede flow (e.g., from medical tubing) to the ports902 and into the canister 918. In some embodiments, the canister 918 canbe separated from and reattached to the stabilizing base 917.

FIG. 9B illustrates a cutaway view of the flow management device 901 ofFIG. 9A while FIG. 9C illustrates a partial view of a component of theflow management device 901 in accordance with various embodiments of thepresent disclosure. The flow management device 901 can include aplurality of first openings 905 passing through a first plate 904 and aplurality of second openings 915 passing through a second plate 907. Thefirst plate 904 can be placed in different rotational positions withrespect to the second plate 907. In some positions of the first plate904, a subset of the plurality of first openings 905 can be placed influid communication with a subset of the plurality of second openings915 to allow passage of gases, fluids, or tissue materials through thefirst plate 904 and second plate 907, and therefore into or out of atreatment system.

The first plate 904 can be coupled to the second plate 907 such that theplates can be moved relative to one another to control flow through thedevice 901. For example, the first plate 904 and second plate 907 can becoupled using a rotatable connection such as a pivot 912 and retainingwashers 910. The flow management device 901 including the first plate904 and the second plate 907 can act as a lid to enclose the tissueprocessing device 900. The first plate 904 can be stationary while thesecond plate 907 rotates with respect to a reference (such as thecanister 918). In some embodiments, the second plate 907 can bestationary while the first plate 904 rotates with respect to a reference(such as the canister 918). In some embodiments, both the first plate904 and the second plate 907 can rotate with respect to a reference(such as the canister 918). In some embodiments, the first plate 904 andthe second plate 907 can include low-friction polymers such as acetal.

Although the first and second plates are depicted in FIG. 9B as flatplates with a round perimeter, it is contemplated that the first andsecond plates could be any shape, dimension, or thickness that does notinterfere with the purposes described herein. For example, the pluralityof first openings and the plurality of second openings can be defined oncurved surfaces such as walls or barriers that can translate, rotate,slide, or otherwise change position with respect to one another.

In addition, the plates can be alternatively replaced with or describedas a barrier wall(s) that can prevent flow of fluid unless openingspassing therethrough are aligned. Accordingly, the devices discussedherein can include a plurality of first openings 905 passing through afirst barrier wall 904 and a plurality of second openings 915 passingthrough a second barrier wall 907. The first barrier wall 904 can beplaced in different rotational positions with respect to the secondbarrier wall 907. In some positions of the first barrier wall 904, asubset of the plurality of first openings 905 can be placed in fluidcommunication with a subset of the plurality of second openings 915 toallow passage of gases, fluids, or tissue materials through the firstbarrier wall 904 and second barrier wall 907, and therefore into or outof a treatment system.

Each of the plurality of first openings 905 or the plurality of secondopenings 915 can be surrounded at an end by a seal 906. The seals 906may be an O-ring, a grommet, or any suitable sealing element. In someembodiments, the seal(s) 906 can be formed of thermoplastic elastomer(TPE) and can be molded concurrently with the first plate 904 or secondplate 907 using a twin-shot molding technique. The seals 906 can createa barrier to prevent gas, fluid, or other material from escaping betweenthe first plate 904 and the second plate 907. The first plate, secondplate, or both can include a plurality of recessed portions 913 sized tofit the seals 906 as shown in FIG. 9D. The seals 906 can be placed intothe recessed portions 913. When the seals 906 are placed in the recessedportion 913, the flow management device 901 is in a stored state thatcan avoid placing compressive forces on the seals 906 when the system isnot used for an extended time such as during shipping or storage. By notsubjecting the seals 906 to long periods of compression, the life of theseals 906 can be extended. In some embodiments, none of the firstopenings 905 is in fluid communication with any second opening 915 whilethe flow management device 901 is in the stored state. Although therecessed portion 906 is illustrated as being in the second plate 907 inFIG. 9D, it is also contemplated that the recessed portions 906 could bein the first plate 904 or both the first plate 904 and the second plate907.

The first plate 904 can include ports 902 to couple tubes 912 to thefirst plate 904. The ports 902 can have a variety of configurations. Inaccordance with various embodiments, the ports 902 may bestraight-walled or barbed; threaded or unthreaded; and have no fittings,luer fittings, swaged fittings, or any other type of connector suitablefor a specific application. Although the ports 902 are depicted asextending out from the body of the flow management device 901, the portsmay also be threaded or unthreaded holes or recesses or may extendinward from the surface into the first plate 904. Although only fourports are depicted in FIG. 9A, any number of ports can be chosen tomatch the number of tubes needed in a particular application. Substancesincluding, but not limited to, gases, liquids, chemical solutions, andbiological tissues can flow into or out from the ports 902 dependingupon the position of the first plate or second plate and therequirements of any particular step of the medical procedure.

The flow management device 901 can include handles 903 to enable a userto more easily rotate one or both of the first plate 904 and the secondplate 907. The handles 903 can be formed integrally with the first plate904, second plate 907, or both or can be formed separately and attached.

In some embodiments, the plurality of first openings 905 can be orientedin one or more lines 909 along the first plate 904 or may be positionedin other arrangements on the first plate 904. In some embodiments, theplurality of second openings 915 can be oriented in one or more lines919 a-919 d along the second plate 907, or can be positioned in othersuitable arrangements on the second plate 907. Each of the lines 919a-919 d can correspond, for example, to one of the steps 402, 404, 406,408 in the decision matrix 400 as described above with reference to FIG.4. For example, the position of the first plate 904 or second plate 907can be adjusted to bring the line 909 including four first openings 905into alignment with the line 919 a including two second openings 915.This operation will place two first openings 905 into fluidcommunication with two second openings 915 as described above for step402 in decision matrix 400. The line 909 can be aligned with other lines919 b-919 d corresponding to the other steps in the decision matrix,respectively.

The flow management device 901 described above with respect to FIGS.9A-9D includes two plates and can operate to restrict the flow byrotating the first plate 904 with respect to the second plate 907. Inother embodiments taught herein below, a flow management device 1000 orsystem can include a third plate sandwiched between the first plate andthe second plate. By changing the position or rotation of the thirdplate, fluid flow can be allowed or interrupted between openings in thefirst plate and the second plate.

FIGS. 10A and 10B illustrate cross-sectional views of portions of flowmanagement devices 1000 in accordance with various embodiments of thepresent disclosure. As shown in FIG. 10A, the flow management device1000 includes a first plate 1004, a second plate 1007, and a third plate1008. In some embodiments, the first plate 1004 can include a pluralityof first openings 1005, the second plate 1007 can include a plurality ofsecond openings 1015, and the third plate can include one or more thirdopenings 1025. By placing the third plate 1008 in different rotationalpositions with respect to the first plate 1004 and the second plate1007, the third openings 1025 can be configured to allow fluidcommunication between a subset of the first openings 1005 and a subsetof the second openings 1015.

In addition, the plates can be alternatively replaced with or describedas a barrier wall(s) that can prevent flow of fluid unless openingspassing therethrough are aligned. Accordingly, the flow managementdevice 1000 includes a first barrier wall 1004, a second barrier wall1007, and a third barrier wall 1008. In some embodiments, the firstbarrier wall 1004 can include a plurality of first openings 1005, thesecond barrier wall 1007 can include a plurality of second openings1015, and the third barrier wall can include one or more third openings1025. By placing the third barrier wall 1008 in different rotationalpositions with respect to the first barrier wall 1004 and the secondbarrier wall 1007, the third openings 1025 can be configured to allowfluid communication between a subset of the first openings 1005 and asubset of the second openings 1015.

In accordance with various embodiments, the third plate 1008 can bedisk-shaped and the one or more third openings 1025 in the third plate1008 can be arranged at the same radial position on the disk or atdifferent radial positions. In some embodiments, the third plate 1008can rotate while the first plate 1004 and the second plate 1007 arestationary.

In some embodiments, the one or more third openings 1025 can besurrounded on one or both sides of the third plate 1008 by a seal 1006.In some embodiments, the seal 1006 may be an O-ring, a grommet, or anysuitable sealing element. The seal 1006 can create a barrier to preventgas, fluid, or other material from escaping between the first plate 1004and the third plate 1008 or the second plate 1007 and the third plate1008. In some embodiments, the first plate 1004, second plate 1007, orthird plate 1008, alone or in any combination, can include a pluralityof recessed portions sized to fit the seals 1006. The recessed portionscan operate as described above with respect to FIG. 9D to protect theseals 1006 from experiencing extended outs of compression. In someembodiments, none of the first openings 1005 is in fluid communicationwith any of the third openings 1025 disposed in the third plate 1008 orwith any second opening 1015 while the flow management device 1000 is inthe stored state.

In some embodiments, the first plate 1004 can include one or more ports1002 to couple tubes 1012 to the first plate 1004 similar to the ports902 described above with reference to FIG. 9A. Each of the one or moreports can be in fluid communication with one of the plurality of firstopenings 1005 in the first plate 1004. In some embodiments, the firstplate 1004 can be coupled to a sidewall 1018 to form an enclosedtissue-processing device.

The multi-position switch 1003 can cause rotation of the third plate1008 with respect to the first plate 1004 and the second plate 1007. Themulti-position switch 1003 can include knobs or dials that rotate or caninclude handles that a user can grip to cause rotation.

In one embodiment the device can include at least two chambers separatedby a filter, membrane, and/or solid wall. By aligning the variousopenings between the two or more plates, access to the chambers can becontrolled. The chambers can be positioned next to each other in aside-by-side configuration or with one chamber on top of the otherchamber. Alternatively, and as described below, a first chamber can bepositioned within a second chamber.

In FIG. 10A, the combined opening formed by the first opening 1005,second opening 1015, and third opening 1025 can be used to draw a vacuumon the interior of the container 1018 using, for example, a vacuum pumpor in-house vacuum provided at a facility. The vacuum can be directedinto the other chamber. In accordance with various embodiments, thesecond plate 1007 can act as a frame to support an inner mesh 1020. Theinner mesh 1020 can contain material such as tissue products whileallowing fluid to pass through. In some embodiments, a transfer port canbe in fluid communication with the interior volume of the container ormesh. In some embodiments, the transfer port can be in fluidcommunication with an inner chamber defined within the inner mesh 1020.Alternatively or additionally, the devices described herein can includeadditional transfer ports that are in fluid communication with thecontainer interior outside the inner mesh 1020.

In FIG. 10B, the combined opening formed by the first opening 1005, thesecond opening 1015, and the third opening 1025 can be used to transportfluids such as Ringer's solution or tissues such as those associatedwith liposuction (i.e., liposuction-derived adipose tissue). In someembodiments, the second opening 1015 can be connected to an innerchamber such that tissue products entering through the second opening1015 are captured inside the inner chamber. In some embodiments, thesecond opening 1015 can be connected to an outer chamber such thatfluids in the outer chamber can be removed through the second opening1015.

As shown in FIGS. 10A and 10B, a portion of the second opening candefine a pathway that directs flow of fluids, gasses, and/or solids intothe inner and/or outer chamber. As shown in FIG. 10B, the second openingcan define a pathway inside the device that directs material into adesired location within the device. In one embodiment, the secondopening has an angled configuration to direct material into the innerchamber of the device. As shown in FIG. 10B, vacuum tubing 1012 can becoupled to the second plate 1007 to extend a pathway into a desiredlocation within the device.

FIGS. 11A and 11B illustrate a cutaway view and an exploded view,respectively, of a tissue treatment system 1100 including an integratedflow management device in accordance with some embodiments of thepresent disclosure. The flow management device is similar to the flowmanagement device 1000 described above with respect to FIGS. 10A or 10B.The tissue treatment system 1100 can include a top cover 1122, a rotaryhandle 1121, a multi-position switch 1103, a first plate 1104 includinga plurality of first openings 1105 therethrough, a second plate 1107including a plurality of second openings 1115 therethrough, a thirdplate 1108 including one or more third openings 1125 therethrough, acontainer 1118, and a filter 1123. When assembled, the tissue treatmentsystem 1100 can be used in some embodiments to process adipose tissueincluding steps such as aspiration, irrigation, mixing, separation, ortransfer. By operating the multi-position switch 1103 coupled to thethird plate 1108, the third openings 1125 can be positioned to allowfluid communication between a subset of the first openings 1105 and asubset of the second openings 1115. In some embodiments, placement ofthe multi-position switch 1103 in a first position can connect a subsetof first openings 1105 to a subset of second openings 1115 that are influid communication with the inner chamber 1140 of the system 1100. Insome embodiments, placement of the multi-position switch 1103 in asecond position can connect a subset of first openings 1105 to a subsetof second openings 1115 that are in fluid communication with the outerchamber 1141 of the system 1100.

In some embodiments, the top cover 1122 can be attached to the container1118 using a snap fit or an adhesive to promote sterility inside thetissue treatment system 1100. In some embodiments, the top cover 1122can include openings or recesses 1124 to connect the first openings 1105to the exterior of the device. In some embodiments, the top cover 1122can fit over or sandwich the multi-position switch 1103.

After cleaning the tissue within the device, it can be important not toallow inadvertent access to the clean tissue to avoid contamination andto maintain sterile conditions within the device. In some embodiments,the second plate 1107 can be permanently affixed to the container 1118.By affixing the second plate 1107 to the container 1118, a seal can beformed that prevents contamination from entering the device. In someembodiments, the second plate 1107 can be affixed to the container 1118using adhesives, heat sealing, or fasteners such as screws.

In accordance with various embodiments, the third plate 1108 can bedisk-shaped and the one or more third openings 1125 in the third platecan be arranged at the same radial position on the disk or at differentradial positions. In some embodiments, the third plate 1108 can rotatewhile the first plate 1104 and the second plate 1107 are stationary. Insome embodiments, the first plate 1104 and second plate 1107 are coupledto sandwich or retain the third plate 1108 between them. As discussedabove with reference to FIG. 10A, the one or more third openings 1125can be surrounded on one or both sides of the third plate 1108 by aseal.

The rotary handle 1121 can extend through the center of the tissuetreatment system 1100 and engage with mixing blades (not shown) in thefilter 1123 or container 1118. By rotating the rotary handle 1121,tissue within the filter 1123 or container 1118 can be mechanicallyprocessed to allow washing or separation of components of the tissue aspart of a tissue treatment regimen. In some embodiments, the filter 1123can be a filter structure as described in greater detail below withreference to FIGS. 16A-18B. In an exemplary embodiment, the filter 1123can act as a dividing wall or barrier to separate an inner chamber 1140from an outer chamber 1141.

In some embodiments, the first plate 1104 can include one or more portsto couple tubes to the first openings 1105 of the first plate 1104similar to the ports 902 described above with reference to FIG. 9A. Insome embodiments, the rotary handle 1121 can engage with a seal 1126that prevents fluids, gases, or tissue components from exiting thefilter 1121 or container 1118. In accordance with various embodiments,the seal 1126 can be integrated into the rotary handle 1121 or into thesecond plate 1107.

The multi-position switch 1103 can cause rotation of the third plate1108 with respect to the first plate 1104 and the second plate 1107 insome embodiments. The multi-position switch 1103 can include knobs ordials that rotate or can include handles that a user can grip to causerotation. In some embodiments, a portion of the multi-position switch1103 can have a complementary shape to a central hole of the third plate1108. For example, the central hole of the third plate 1108 can beshaped as a pentagon or other polygonal shape and the portion of themulti-position switch 1103 can be shaped as a pentagon that fits withinthe hole of the third plate 1108. The complementary shapes of theportion of the multi-position switch 1103 and the central hole of thethird plate 1108 can enable the multi-position switch 1103 to engage androtate the third plate 1108 in some embodiments.

In some embodiments, the second plate 1107 can be coupled to thecontainer 1118 using a snap fit or adhesive fit.

FIGS. 12A and 12B show a cutaway view and an exploded view,respectively, of an alternative embodiment of a tissue treatment system1100′ including an integrated flow management device. The flowmanagement device is similar to the flow management device describedabove with respect to FIGS. 10A or 10B. The primary difference betweenthe tissue treatment system 1100 of FIGS. 11A-11B and the tissuetreatment system 1100′ of FIGS. 12A and 12B relates to componentintegration and manufacturing. The tissue treatment system 1100′ caninclude a valve assembly 1114 that includes the first plate 1103, thesecond plate 1107, and the third plate 1108. The tissue treatment system1100′ can also include a filter top 1137 that includes a plurality ofthird openings 1125 that connect the interior of the container 1118 andthe second openings 1115 of the second plate 1107. By operating themulti-position switch 1103 coupled to the third plate 1108, the thirdopenings 1125 can be positioned to allow fluid communication between asubset of the first openings 1105 and a subset of the second openings1115 thereby also placing a subset of the third openings 1135 in fluidcommunication with the subset of the first openings 1105.

After cleaning the tissue within the device, it can be important not toallow inadvertent access to the clean tissue to avoid contamination andto maintain sterile conditions within the device. In some embodiments,the filter top 1137, top cover 1122, or both can be permanently affixedto the container 1118. By affixing the filter top 1137 and the container1118, a seal can be formed that prevents contamination from entering thedevice. In some embodiments, the filter top 1137, top cover 1122, orboth can be affixed to the container 1118 using adhesives, heat sealing,or fasteners such as screws.

The filter top 1137 can be coupled with the filter 1123 using a snap fitor an adhesive fit. In some embodiments, the filter assembly 1114 can bereplaceable or interchangeable. In some embodiments, the tissuetreatment device 1100′ can be provided with multiple filter assemblies1114 that are configured to correspond to different sets of tissuetreatment protocols. In such embodiments, the user can select a filterassembly 1114 to fit their application at the beginning of the procedureand can snap the filter assembly 1114, multi-position switch 1103,rotary handle 1121, and top cover 1122 in place.

Embodiments described above include one or more walls or barriers suchas flat plates to restrict or allow flow between the first openings andthe second openings. In alternative embodiments described below withrespect to FIGS. 13A-14B, different components such as cylindricalspindles or diaphragm values provide the capability to restrict flowbetween first and second openings.

FIG. 13A depicts a flow management device 1300 including a spindle inaccordance with various embodiments of the present disclosure. FIG. 13Billustrates a cross-sectional view of the flow management device 1300.The flow management device 1300 includes a body 1301 having a pluralityof first openings 1302 and a plurality of second openings 1312, aspindle 1307 coupled to a multi-position switch 1303 and a plurality ofthird openings 1315. By operating the multi-position switch 1303, thespindle 1307 can rotate in a direction 1320. Operation of themulti-position switch 1303 can position some or all of the thirdopenings 1315 to place a subset of the first openings 1302 into fluidcommunication with a subset of the second openings 1312.

In some embodiments, the plurality of third openings 1315 can includemore than one opening each axial position of the spindle 1307. In suchembodiments, different openings at the same axial position can havedifferent azimuthal trajectories. The use of multiple openings at thesame axial position along the spindle 1307 can increase the number ofpossible connection configurations for a given spindle 1307. Accordingto the rotational orientation of the spindle 1307, each of the thirdopenings 1315 can connect one of the first openings 1302 to one of thesecond openings 1312.

In some embodiments, seals 1306 may be placed at positions along thespindle 1307 to obstruct the passage of fluid, gas, or tissue materialbetween the spindle 1307 and the body 1301. The seals 1306 can beO-rings, grommets, or gaskets and can be made of rubber, polymer, or anyother suitable material. In some embodiments, the seals 1306 can beformed of thermoplastic elastomer using a molding technique such astwin-shot molding.

The multi-position switch 1303 can be integrated directly into thespindle 1307 in some embodiments or can be a separate device that causesthe spindle 1307 to rotate. In some embodiments, the multi-positionswitch 1303 can be operated by hand. In some embodiments, themulti-position switch 1303 can be optimally shaped to enable the use oftools such as wrenches to improve a user's leverage in setting themulti-position switch 1303. Although the multi-position switch 1303 isshown rotating in direction 1320 in FIG. 13A, the multi-position switch1303 can be rotated in either direction in some embodiments.

The body 1301 can include ports or connections adjacent to the firstopenings 1305 or the second openings 1315 that allow connection to avariety of different tubes or hoses. For example, the ports orconnections adjacent to the first openings 1305 or the second openings1315 can include barbs, threads, fittings or other appropriateconnectors.

FIGS. 14A and 14B illustrate a flow management device 1401 including adiaphragm valve in open and closed positions, respectively, according tovarious embodiments of the present disclosure. The flow managementdevice 1401 can include a rotating plate 1404, and one or more diaphragmunits 1450. The diaphragm unit 1450 can include a flexible diaphragm1455 and an inner chamber 1451. The flexible diaphragm 1455 can beactuated to open or close fluid pathways in the flow management device1401. In some embodiments, the diaphragm 1450 can include materials suchas silicone. In some embodiments, the diaphragm 1455 can include a boss1456.

In an open position, the diaphragm unit 1450 places a first opening1405, inner chamber 1451, and second opening 1415 into fluidcommunication. In a closed position, the first opening 1405 of thediaphragm unit 1450 is no longer in fluid communication with the innerchamber 1451 or the second opening 1415.

The rotating plate 1404 can include one or more protrusions 1414. Insome embodiments, the rotating plate 1404 can be rotated to differentrotational positions with respect to the diaphragm units 1450. Byrotating the rotating plate 1404, a protrusion 1414 can be positionedbelow the diaphragm unit 1450. The protrusion can force the flexiblediaphragm 1455 upwards to seal the boss 1456 against the one or morefirst openings 1405 passing through the diaphragm unit 1450 therebyplacing the diaphragm unit 1450 in a closed position. By sealing the oneor more first openings 1405, the diaphragm 1450 can interrupt fluidcommunication between the first openings 1405 and second openings 1415.

In some embodiments, a separate diaphragm unit 1450 can be supplied foreach fluid connection that is to be controlled. In some embodiments, asingle diaphragm unit can include more than one boss 1456, more than onefirst opening 1405, or more than one second opening 1415. In someembodiments, rotating plate 1404 can have small patterns of protrusions1414 at different azimuthal positions on the plate 1404 tosimultaneously provide control of multiple diaphragm units 1450 for eachposition of the rotating plate 1404.

In FIG. 15A, a tissue treatment system 1530 is illustrated that includesa turbine 1520 in accordance with various embodiments. The turbine 1520can turn the mixing shaft 1535 including mixing blades or paddles 1534to agitate the tissue inside the tissue treatment system. The turbine1520 can include a rotor with a central shaft 1521 and rotor blades 1528as shown in FIG. 15C. In some embodiments, the turbine 1520 can have anair intake 1522 and air outlet 1525. Upon attachment of the air outlet1525 to a source of negative pressure such as a vacuum pump, the rotorblades 1528 will move thus turning the central shaft 1521.

As shown in FIG. 15B, the end 1526 of the central shaft 1521 can engagewith the mixing shaft 1535 so that the central shaft 1521 and mixingshaft 1535 rotate in concert. In accordance with various embodiments,the engagement of the central shaft 1521 with the mixing shaft 1535 cantake any suitable form. For example, as shown in FIG. 15B, the end 1526of the central shaft 1521 can have a hexagonal cutout that matches ahexagonal extension on the mixing shaft 1535. Other shapes are alsopossible including squares, stars, and other polygons. In someembodiments, the turbine 1520 can be separated from the base of thetissue treatment system 1530, and a manually operated rotation systemsuch as a rotary handle can be installed in its place. In someembodiments, the separable turbine 1520 can be sterilizable or reusableto allow use of a single turbine 1520 for multiple tissue processingprocedures with multiple tissue treatment canisters or containers. Insome embodiments, the turbine 1520 can be disposable.

Because a solution including washing fluids and adipose or other tissuescan be viscous, a user that is manually agitating the tissue may becomefatigued before the washing sequence is complete. In addition, theagitation may be inconsistent if the user varies the speed of rotationof the rotary handle throughout the washing sequence. Rotation of themixing shaft 1535 using a turbine 1520 can improve consistency ofmixing. For example, a constant level of negative pressure applied atthe air outlet 1525 can cause the mixing shaft 1535 to rotate at aconstant rate of rotation. In addition, the turbine 1520 can operate ata consistent speed for an extended period of time as necessary accordingto the needs of the practitioner.

FIG. 15D illustrates a modification to the turbine wherein a smallergear 1540 is attached to the central shaft 1521. The teeth of thesmaller gear 1540 can engage with teeth on a larger gear 1541 attachedto the mixing shaft 1535. In some embodiments, the ratio of sizes of thesmaller gear 1540 and the larger gear 1541 can be chosen to optimizerotations per minute of the mixing shaft 1535 for adipose tissuewashing. In some embodiments, the tissue treatment system 1530 caninclude multiple removable and attachable small gears 1540 or largegears 1541 to enable a practitioner to tune the gear ratio and, thus,the speed of rotation to the desired level.

FIG. 16 illustrates a tissue treatment system 1600 including a volumemeasurement device 1610 in accordance with various embodiments of thepresent disclosure. In some embodiments, the volume measurement device1610 can include a spring 1620 and needle gauge 1612. In accordance withvarious embodiments, the spring 1620 can be calibrated to compress by aspecific distance for a given applied force. The spring 1620 can beplaced below a vessel that holds the tissue in the tissue treatmentsystem. For a given weight of tissue in the tissue treatment system1600, the spring 1620 can compress a prescribed distance, and the needlegauge 1612 can indicate the mass of tissue present. In some embodiments,the needle gauge 1612 can be visible through a window 1614 in theexterior wall of the tissue treatment system 1600. In some embodiments,the needle gauge 1612 can indicate values on a scale 1616. The scale1616 can be labeled in mass units or volume units.

FIGS. 17A and 17B illustrate one embodiment of a filter structure thatcan divide first and second portions or chambers of the devices andsystems described herein. The dividing wall defined by the filterstructure can include a frame member 1725 that provides structuralsupport. Frame member 1725 can be formed of a material that providesrigidity and is formed from solid material. In one aspect, the framemember 1725 is formed of liquid-impervious material. Frame member 1725can mate with or be formed integral with a top portion of the device.For example, the frame member 1725 can mate with or be formed integralto a second plate 1107 as described above with reference to FIG. 11A.The bottom portion 1726 of the frame member 1725 can define a transferport 1730 for removal of materials from within the inner chamber of thedevice adjacent to the bottom portion of the device. In one aspect,frame member 1725 extends from the top portion of the interior of thedevice to the bottom of the interior of the device. In some embodiments,the frame member 1725 can surround an upper border of the filter 1710 ormesh wall. In additional embodiments, the frame member 1725 can extendalong at least a portion of a side wall of the mesh wall to a bottomportion of the mesh wall.

Frame member 1725 can include a window 1727 defined by the frame member.Various filters 1710 can be mated with the frame member to allowmovement of liquid and gas from between the inner and outer chambers ofthe device. The filter 1710 can be mated within one or more windows1727. For example, as shown in FIG. 17B, a window defined between thetop and bottom portions of the frame member can include a filter 1710.The filter 1710 can define a portion of the dividing wall that dividesthe first and second chambers of the device. In one embodiment, thefilter and/or filter windows do not extend to the top most part and/orbottom most part of the frame member. Alternatively, a single filter1710 can be seated within the frame member. In some embodiments, thefilter 1710 can be a mesh wall supported by the frame or frame memberthat acts to divide the first chamber from the second chamber.

In some embodiments, a mesh filter 1710 as shown in FIG. 17A can have aconical shape. In various embodiments, the narrow end of the mesh filter1710 can come to a point or a line seam, or the mesh filter 1710 canhave a flat panel on the bottom. In some embodiments, the cone shape ofthe mesh filter 1710 can smooth out areas where adipose tissue or othertissue components can get stuck. As shown in FIG. 17B, a mesh filter1720 can also include a superstructure 1725 to provide greater form andstability to the mesh filter 1720. In some embodiments, thesuperstructure of the frame member 1725 can be overmolded plastic. Insome embodiments, the mesh filter 1720 can include an integratedtransfer port 1730. The transfer port 1730 can be used to extract tissuefrom a tissue treatment system after washing, separating, and mixingcycles are complete.

FIG. 17C illustrates a straight-walled mesh filter according to variousembodiments of the present disclosure. Use of a straight-walled meshfilter can allow use of mixing blades of equal length from top to bottomof the shaft. The frame member 1725 of the mesh filter 1710 can promotea “squeegee” effect to help remove material from the mesh filter 1710and reduce waste during extraction. In some embodiments, the framemember 1720 can include a transparent material to improve visibility ofthe contents within the mesh filter 1710.

FIGS. 18A and 18B illustrate a disassembled and assembled filterstructure 1810, respectively, according to various embodiments of thepresent disclosure. The filter structure 1810 can include a frame member1850 and a filter 1815. The frame member 1850 can include one or morewindows 1827. In some embodiments, the filter 1815 can be mated withinthe windows 1827.

In some embodiments, the filter 1815 can include cut-through holes 1816to hold the filter in place against the frame member 1850. In someembodiments, the frame member 1850 can include a boss feature 1856 orother catch feature to engage with the cut-through holes 1816 andposition the filter 1815. In accordance with various embodiments, thefilter 1815 can be cut to fit the frame member 1850 such that removedportions 1818 of the filter 1815 line up with solid portions 1858 of theframe member 1850. In some embodiments, the solid portions 1858 compriseextensions from the frame member 1850. The frame member 1850 cansurround an upper border of the filter 1815 and have multiple solidportions 1858 as extensions along at least a portion of a side wall ofthe mesh wall to a bottom portion of the mesh wall. In accordance withvarious embodiments, the filter 1815 can include a synthetic or naturalmesh-like material.

The filter structure 1810 can include a transfer port 1860 near thebottom of the filter structure. In prior systems, removal of cleanedtissue from the tissue treatment system generally required inversion ofthe tissue treatment system to bring the tissue in proximity to anentry/exit port at the top of the device. In this case, inversion of thedevice is undesirable as it requires the device to be completelydisconnected from attached tubing and awkwardly held upside-down by apractitioner. Alternatively, a separate port having an extension tubewas used to extract clean tissue from the device. In this case, the tubetypically presented an obstruction to the motion of the mixing blades,and tissue trapped near the tube did not properly wash or mix. Inembodiments of the present disclosure, the transfer port 1860 can allowremoval of tissue from the tissue treatment system through or near thebottom of the container. The tissue can be drawn into the transfer port1860 by gravity or through the application of negative pressure. In someembodiments, the transfer port 1860 can be used to extract fluids,gases, or solids or can be used to insert fluids, gases, or solids. Incertain embodiments, the transfer port 1860 can be in fluidcommunication with the inner chamber of a tissue treatment device asdescribed above with reference to FIGS. 11A and 12A. In otherembodiments, the transfer port 1860 can be in fluid communication withthe outer chamber of the tissue treatment device. In some embodiments, aportion of the transfer port 1860 can be equipped to engage withsyringes of various sizes, luer locks, or any other suitable connector1861.

FIG. 18C illustrates a tissue treatment system 1800 including a filterstructure 1810 in accordance with various embodiments described herein.The tissue treatment system 1800 can include a plurality of ports 1802,one or more mixing blades 1830, a base 1870, and a filter structure1810.

As described above with reference to FIGS. 18A-18B, the filter structurecan divide first and second portions or chambers of the tissue treatmentsystem 1800. The dividing wall defined by the filter structure 1810 caninclude a frame member 1850 that provides structural support. In variousembodiments, frame member 1850 can mate with or be formed integral witha top portion of the device. For example, the frame member 1850 can matewith or be formed integral to a second plate 1107 as described abovewith reference to FIG. 11A. In some embodiments, the filter structure,top portion, and bottom portion of the device including a transfer port1860 can be built into one interior wall of the device. The bottomportion of the frame member 1850 can define a transfer port 1860 forremoval of materials from within the inner chamber of the deviceadjacent to the bottom portion of the device. In one aspect, framemember 1850 extends from the top portion of the interior of the deviceto the bottom of the interior of the device. In some embodiments, theframe member 1850 can surround an upper border of the filter 1815 ormesh wall. In additional embodiments, the frame member 1850 can extendalong at least a portion of a side wall of the mesh wall to a bottomportion of the mesh wall.

The manual forces that are applied to operate the handle 1804 toproperly mix and wash tissue using the mixing blade(s) 1830 may besignificant for some forms of tissue. In a typical setup, tissue washingand mixing will occur after other steps in a surgical procedure havealready been performed such as tissue extraction. Mid-operation, theexamination gloves worn by the surgeon or practitioner may containforeign matter or fluid of a slippery nature that can make it difficultto grasp and operate the handle without tipping over the device. Inaccordance with various embodiments, the tissue treatment system 1800can include a wide base 1870 (or 917 in FIG. 9A) at the bottom of thesystem to improve stability and prevent tipping or movement of thedevice during tissue mixing and washing. In some embodiments, theunderside of at least a portion of the wide base 1870, 917 can include ahigh-friction, textured, or tacky substance such as rubber to preventslipping or skidding of the tissue treatment system 1800 during use. Insome embodiments, the wide base 1870, 917 can include fluids, metals, orother high density materials to provide additional weight to the base.

The wide base is illustrated with a couple of specific configurations,but it should be understood that the base can be modified to accomplishany one or more of maintaining device stability and preventingaccidental tipping or movement. The base can include a flared outwardsection or other configurations (e.g., a box, a series of extensions, ormultiple legs). The base can be defined by a widened section, forexample, having a footprint or widest dimension that is 10%, 20%, 30%,40% or more greater than the widest dimension of the lowest portion ofthe container of the treatment system, or 10%, 20%, 30%, 40% or moregreater than the widest dimension of the top of the treatment system(thereby preventing a top-heavy or unstable structure).

In some embodiments, the tissue treatment device 1800 can include amulti-position switch 1806. The multi-position switch can operate toplace different subsets of first openings in fluid communication withsubsets of second openings as described above with reference to FIGS.9A-12B.

FIG. 19A illustrates an exploded view of a conical filter structure 1910for use in tissue treatment systems according to various embodiments ofthe present disclosure. Although illustrated in conjunction with aparticular treatment system, the filter structure can be incorporatedwith any of the aforementioned tissue treatment systems describedherein. As discussed further below, the filter structure can include afiltering portion or mesh structure that allows flow of fluid or debrisof a selected size, while retaining tissue to be treated and/orimplanted. In addition, the structure includes a frame, which caninclude a rigid, semi-rigid, or otherwise strong material to support thestructure. The frame and filtering portion or mesh, together provideimportant advantages.

For example, known filters, such as polymeric meshes, may be prone tobreakage, especially with vigorous washing or transfer processes.Accordingly, the frame, in its various possible configurations, allows amore robust structure that is less prone to failure during surgicalprocessing. In addition, the filter can extend towards or all the way tothe bottom of the treatment system. The extension to the bottom of thetreatment system can allow formation of supporting side walls in theframe, and can allow further support of the filter by the bottom wall ofthe system. In addition, the filter, by extending toward the bottom ofthe system and including a frame, which itself can extend to and form abottom portion of the filter, can be configured to engage with one ormore transfer ports, thereby allowing insertion and/or extraction offluids and tissue from the system's bottom—thereby obviating the needfor top-only access using syringes or other devices.

Specific details of an exemplary filter are described as follows, butthe general principals of the desirable filter structure can beunderstood from the foregoing and can be applied to filters used in anyof the presently described tissue treatment systems and methods. Thefilter structure 1910 can include a filter 1915 and one or more rigidrings. In an exemplary embodiment, the filter 1915 can be formed of asingle piece of material such as a mesh-like material that is sealed ata single seam. By using a single seam, the amount of mesh sealing thathas to be performed during production can be reduced. In someembodiments, the filter structure 1910 can include an upper rigid ring1922 and a lower rigid ring 1924. The upper rigid ring 1922 can includea sealing surface 1924 and a ridge 1925. In various embodiments, thesealing surface 1924 can be flat to allow for heat sealing or ultrasonicwelding of the filter 1915 to the sealing surface 1924. The lower rigidring 1924 can include a flat surface to facilitate heat sealing orultrasonic welding of the filter 1915 to the lower rigid ring 1924. Therigid rings can be formed of plastic or any other suitable materialincluding, but not limited to, metals or glass. In some embodiments, thefilter 1915 can include a synthetic or natural mesh-like material. Thefilter 1915 can be a mesh wall that divides a first chamber from asecond chamber. In some embodiments, the upper rigid ring 1922 can be aportion of a frame that surrounds the upper border of the filter 1915such as a mesh.

FIG. 19B illustrates placement of the filter structure of FIG. 19A in atissue treatment system according to various embodiments of the presentdisclosure. In some embodiments, the tissue treatment system can includean exoskeleton 1950. In an exemplary embodiment, the ridge 1925 on theupper rigid ring 1922 can engage with a shelf feature 1952 in theexoskeleton 1950. The engagement of the upper rigid ring 1922 andexoskeleton 1950 can include a sealing or press-fit step to let anassembler or practitioner know that the elements are engaged. In someembodiments, the lower rigid ring 1924 can be bonded or heat sealed tothe exoskeleton 1950 to fix the mesh filter 1910 in place or to preventleakage of tissue or fluids from within the mesh filter.

FIG. 19C illustrates a cross-sectional view of a filtering structure1910 according to embodiments of the present application. The filteringstructure 1910 can include the filter 1915, the upper rigid ring 1922,and an elastomeric O-ring 1932. The upper rigid ring 1922 can have arecess 1931 such as a groove. The elastomeric O-ring 1932 can be sizedto fit tightly within the recess 1931. By pinning the filter 1915 in therecess 1931 using the elastomeric O-ring 1932, a tight seal is formed atthe top of the filtering structure 1910 through which solids cannot passin some embodiments.

FIGS. 19D and 19E illustrate a pre-form 1965 for a filtering structure1910 and the finished filtering structure 1910, respectively, inaccordance with various embodiments of the present application. Thepre-form 1965 can be produced in a variety of suitable shapes. In someembodiments, the pre-form 1965 can have an axis of symmetry 1966 aboutwhich the pre-form can fold to produce the finished filtering structure1910. Because the pre-form 1965 is typically a single flat piece ofmaterial, it can be manufactured using less complex machining techniquessuch as punching or die-cutting. In some embodiments, the pre-form 1965can be folded and sealed to form the filtering structure 1910. Forexample, the edges 1966 of the pre-form 1965 can be heat-sealed,crimped, or pressed to achieve a seal that will not allow passage ofsolid materials. As a result, the filtering structure 1910 can have apocket-like shape akin to a coffee filter in some embodiments.

FIGS. 20A and 20B illustrate two configurations of telescoping mixingpaddles for use in tissue treatment systems according to variousembodiments of the present disclosure. In accordance with variousembodiments, the telescoping mixing paddle 2010 can convert to operateas both mixing paddles and as a piston or plunger. In an exemplaryembodiment, the telescoping mixing paddle 2010 has blades at a firstaxial position 2012 and a second axial position 2014. In someembodiments, blades at different axial positions can rotate with respectto one other during the conversion from mixing form and piston form.Although the telescoping mixing paddle 2010 shown in FIGS. 20A-20D hasblades at two axial positions, it is contemplated that blades could beat any number of axial positions along the paddle. The mixing paddle2010 can be converted to a piston form as shown in FIG. 20B by bringingthe blades at the first axial position 2012 and blades at the secondaxial position 2014 together at the same axial position. This can beaccomplished by moving the blades at the first axial position 2012, theblades at the second axial position 2014, or both. In an exemplaryembodiment, the piston form of the mixing paddle 2010 can have acomplete bottom surface without significant gaps in the surface thatwould allow tissue to pass through.

FIGS. 20C and 20D illustrate side views of tissue treatment systems withtelescoping mixing paddles in accordance with various embodiments. Thetelescoping mixing paddle 2010 is shown in mixing form in FIG. 20C andpiston form in FIG. 20D. At the end of a tissue washing cycle, thepiston form of the telescoping mixing paddle 2010 can be used to helpextract tissue from the tissue treatment system. In the piston form, auser can press on an end 2015 of the telescoping mixing paddles in thepiston form to force tissue towards an extraction port 2030 in thetissue treatment system.

FIGS. 21A-21D illustrate telescoping mixing paddles for use in tissuetreatment systems according to various embodiments of the presentdisclosure. As shown in FIG. 21A, the telescoping mixing paddles 2110can include a release button 2116 on an end 2115 of the paddles. In someembodiments, the release button 2116 can release a detent that allowsthe blades at different axial positions along the telescoping mixingpaddle to be brought to the same axial position to form a piston orplunger. In some embodiments, the telescoping mixing paddles 2110 can beused in cooperation with mesh filter 2150 including a rigid moldedexoskeleton 2152 and a mesh 2155. The rigid molded exoskeleton 2150 cangive structure to the mesh filter 2150 that keeps the mesh 2155 in closecontact with the outer edge of the blades of the telescoping mixingpaddles 2110. The close contact between the blades and the mesh canenable efficient plunger action when the telescoping mixing paddles 2110are in the piston form thereby improving extraction. FIG. 21Billustrates the telescoping mixing paddles 2110 in the expanded mixingor agitation mode to mix harvested fat and/or other tissue with cleaningor rinse solutions. FIG. 21C illustrates conversion of the telescopingmixing paddles 2110 from mixing mode to piston mode. In this embodiment,blades at the second axial position are raised up to the first axialposition. In some embodiments, the blades can be locked in this positionto assist in extracting rinsed and cleaned tissue. In FIG. 21D, thetelescoping mixing paddles 2110 in the piston form can be pushed down toforce the tissue to exit via an extraction port at the bottom of thedevice.

FIGS. 22A and 22B illustrate a tissue treatment system including amixing device with a disc portion that can be opened or closed for useas an ejection piston in accordance with various embodiments of thepresent disclosure. The tissue treatment system 2200 can include a meshcanister 2250 into which a central shaft 2220 passes. The central shaft2220 can include mixing blades 2230, a disc portion 2240, a handle 2214,and a rotating top lever 2212. During mixing and cleaning of tissue,open portions 2242 of the disc portion 2240 can allow tissue to travelthrough the disc portion. When the tissue has been cleaned and is readyfor extraction, the central shaft 2220 can be slid up similar to aFrench press. In an exemplary embodiment, the rotating top lever 2212can be rotated to place solid panels 2243 in the open portions 2242 ofthe disc portion 2240 thereby blocking the open portions. To enhancetissue extraction, the now solid disc portion 2240 can be lowered bypressing down on the central shaft 2220 to force tissue out of anextraction port 2260 at the bottom of the canister 2250.

FIGS. 23-25 illustrate tissue treatment systems including mixing andauger systems to facilitate tissue extraction. FIG. 23 illustrates atissue treatment system with a mixing and auger system to facilitatetissue extraction in accordance with various embodiments of the presentdisclosure. The mixing and auger system can include a central shaft 2320that passes into an overmolded clear plastic mesh canister 2350. Thecentral shaft 2320 can include mixing blades 2330, a handle 2314, and anauger 2335. In some embodiments, turning the rotating handle 2314 in onedirection (e.g., clockwise) will mix tissue using the mixing blades 2330while turning the rotating handle 2314 in the opposite direction (e.g.,counter-clockwise) will auger the tissue to an extraction port 2360 atthe bottom of the tissue treatment device 2300. FIGS. 24A and 24Billustrate perspective and top views of the mixing and auger system ofFIG. 23 in a tissue treatment system in accordance with variousembodiments of the present disclosure. FIGS. 25A and 25B illustratealternative embodiments of mixing and auger systems to facilitate tissueextraction in accordance with various embodiments of the presentdisclosure. In accordance with various embodiments, the auger 2335 canbe relatively wide (as illustrated in FIG. 25B) or narrow (asillustrated in FIG. 25A).

FIGS. 26A and 26B illustrate alternative embodiments of motorized tissuetreatment systems in accordance with various embodiments of the presentdisclosure. In some embodiments, the motorized system can include abattery-powered motor 2601 to automatedly rotate the mixing blades. Themotorized system can include a button 2602 to start and stop the motor2601. In some embodiments, the motorized system can include aspring-loaded wind-up mechanism 2604 and a button. The spring-loadedwind-up mechanism can be wound using a knob 2606. In a preferredembodiment, a user can turn the knob 2606 to wind-up the wind-upmechanism 2604 and press the button to begin agitation. In accordancewith various embodiments, the motorized system can rotate a central ormixing shaft at a controlled speed for a controlled duration. The use ofcontrolled speed can ensure that the speed stays within maximum orminimum bounds, which can provide proper agitation without additionalstress on the tissue. The ability to mix for a controlled duration canimprove usability by allowing a user to attend to other tasks whilemixing occurs and by reducing fatigue in the user after extended manualmixing.

FIG. 27A illustrates a transparent open view of the motorized system toagitate tissue shown in FIG. 26B in accordance with various embodimentsof the present disclosure. The motorized system can include a knob 2706and a ratchet mechanism. The ratchet mechanism can include a gear 2712and a pawl 2714. A spring-loaded wind-up mechanism 2704 can be wound byturning the knob 2706. The pawl 2714 prevents the gear 2712 fromunwinding. Activation of the button in some embodiments can release thepawl 2714 so that the gear 2712 can slowly unwind while poweringrotation of mixing blades 2730.

FIGS. 27B and 27C illustrate perspective and top views, respectively, ofa motorized or powered tissue treatment device 2700 according to variousembodiments. In some embodiments, the motorized tissue treatment device2700 can include a knob 2706 to operate a wind-up mechanism as describedabove to drive motion of the mixing blades 2730. The button 2722 can beused to release the energy stored in the system after winding up theknob 2706. The tissue treatment device 2700 can include vent ports 2721to fluidically connect the interior of the device 2700 with the externalenvironment. In some embodiments, the vent ports 2721 can be sealed orunsealed by operation of rotating vent seals 2727. The vent seals 2727can include a sealing element such as a rubberized surface or O-ring toimprove the seal around the vent port 2721 in some embodiments. Thetissue treatment system 2700 can also include one or more valves 2728connected to ports 2702 to control flow into and out of individual ports2702. Valves 2728 connected individually to ports 2702 provide a simplesolution to opening and closing access to the ports 2702 whileperforming steps in a tissue treatment procedure. Unlike clamping ofhoses using loose clamps that can be misplaced or dropped (thus losingsterility), the valves 2728 can be integrated with the device 2700.

The tissue treatment device 2700 can also include a wide base 2770similar to those described above for other embodiments. The wide base2770 can include indentations 2771 to facilitate gripping of the device2700 by the user. In some embodiments, the indentations 2771 can beformed during molding of the wide base 2770. In some embodiments, theindentations 2771 can include overmolded portions. The overmoldedportions can include a rubberized material to improve grip of the deviceby the user.

FIGS. 28A and 28B illustrate a tissue treatment system including asterile drape in accordance with various embodiments of the presentdisclosure. In some embodiments, the sterile drape 2810 can comepre-attached to the canister or container of the tissue treatment system2800. The sterile drape 2810 can be stretched over a working surface andadhered to the underside of the surface. In some embodiments, thesterile drape 2810 can include an adhesive. In some embodiments, thesterile drape 2810 can be sized to fit over a Mayo stand or other traycommonly found in surgical environments. Because various surgicalprocedures may have already occurred before use of a tissue treatmentsystem occurs, a sterile drape 2810 attached directly to the tissuetreatment system 2800 can quickly provide a practitioner with a sterilesurface for tools by simply extending over and covering surfaces thatmay have been contaminated during earlier procedures.

FIGS. 29A-D illustrate a tissue treatment system 2900 including a baseand a replaceable tissue processing unit in accordance with variousembodiments of the present disclosure. The top cover 2915 of the baseunit 2910 can lift to allow for insertion of the tissue processing unitincluding a container or canister 2920 and tube manifold assembly 2925.The top cover 2915 can be lowered for operation. In some embodiments, arotating handle mechanism 2921 can be integrated into the base unit 2910while the mixing blades can be integrated into the canister 2920. Theuse of a two-component system (base unit 2910 and canister 2920/tubemanifold assembly 2925) can reduce per-unit costs for some portions ofthe system 2900. In some embodiments, the base unit 2910 can be reusedfor multiple procedures while the canister 2920 and tube manifoldassembly 2925 can be single use and/or disposable. In some embodiments,the base unit 2910 can be sterilizable. In some embodiments, the baseunit 2910 can be secured to a surface, e.g., table, during use tostabilize the base unit 2910. By securing the base unit 2910, the system2900 is less likely to tip during mixing, agitation, or stirring of thecontents of the system 2900.

FIGS. 30A and 30B illustrate a tissue treatment system 3000 including atube management device according to various embodiments of the presentdisclosure. In an exemplary embodiment, the system 3000 can use atube-switching mechanism such as the flow management device 1000described above with reference to FIG. 10A. The lid of the system 3000can include holes 3001 to allow a portion of a plate (e.g., the firstplate) to be seen through the holes 3001. In some embodiments, each hole3001 can be associated with a port and can include an annotation 3002that identifies the function of the port. Example annotations 3002 caninclude “Lipo,” “Rinse,” “Vent,” and “Vacuum.”

In some embodiments, the uppermost plate of a tube management system canbe imprinted with writing or labels 3005 that indicate the currentstatus of the tubing connections. For example, the plate can include“X”s that align with the holes 3001 when the plates within the tubemanagement system are aligned correctly for a particular step in atissue processing operation. Several exemplary arrangements of thelabels 3005 as seen through the holes 3001 are shown in FIG. 30B. As anexample, labels 3005 can appear in the holes 3001 corresponding to thevent and rinse ports during the drain phase to indicate that these portsare closed while the remaining ports (i.e., lipo and vacuum) are openand do not have labels 3005 appearing in corresponding holes 3001.Labels can be positioned on the plate to appear in holes as required toconvey the open and closed status of ports for a variety of phases ofthe tissue processing operation, e.g., the liposuction, rinse,agitation, drain, and extraction phases. As described herein, thepresence of a label 3005 indicates that a port is closed while thoseholes 3001 that do not have a label 3005 indicate ports that are open.However, one of ordinary skill in the art will appreciate that thelabeled holes 3001 could indicate corresponding open ports whileunlabeled holes 3001 could indicate closed ports.

FIGS. 31A-31D illustrate views of an alternative embodiment of a tubemanagement device to that of FIGS. 30A-30B. In the depicted tubemanagement device 3110, an indicator switch 3103 can point to anannotation 3113 that describes the current phase of the tissueprocessing procedure. That is, the indicator switch 3103 may not providethe user with direct information as to the open/closed status of anygiven port but can provide the user instead with information regardingthe current step of the tissue processing procedure. In this way, theindicator switch 3103 can guide the user through the steps of action andopen/close the corresponding connections for each step as described ingreater detail below. Exemplary annotations 3113 can include “Harvest,”“Wash,” “Filter,” and “Extract” in some embodiments. The use of anindicator switch 3103 as described herein above can eliminate the needfor disconnections and connections of tubes to the ports 3102 as thetubes can be left connected throughout the procedure.

In some embodiments, the indicator switch 3103 can be configured toallow control of the second plate or third plate of a tube managementdevice as described above with reference to FIGS. 9A-10B. In otherembodiments, the tube management device 3110 can include an outer lid3105 and an inner lid 3111 as described below.

FIG. 32 illustrates a view from below of the tissue treatment system ofFIG. 32A. As shown, the tube management device 3110 can include an outerlid 3111 and an inner lid 3112 seated within and rotatable relative tothe outer lid 3111. In some embodiments, the inner lid can include aplurality of holes 3115 at various locations around the periphery of theinner lid 3112. Similarly, the outer lid 3111 can include a plurality ofports 3102 that are engageable with tubes to deliver tissue,fluids/solutions, or vacuum pressure to the system 3100. As theindicator switch 3103 is rotated, the inner lid 3112 can rotate withrespect to the outer lid 3111 to bring a subset of the holes 3115 intofluid communication with one or more of the ports 3102. For example,when the indicator switch 3103 is pointing to the annotation for “Wash,”the holes 3115 and ports 3102 align for the tubes for venting andcarrying solution into the device can be connected while other holes arenot connected. As shown in FIG. 32, some holes 3115 are fluidicallyconnected to the interior of the container and internal to the filteringstructure while other holes 3115 are fluidically connected to theinterior of the container external to the filtering structure.

In some embodiments, sealing elements can be overmolded onto surfaces ofthe inner lid 3112 or outer lid 3111 to prevent leaking into the spacebetween them. In some embodiments, each hole 3115 can be surrounded by acollar. In such an embodiment, the outer lid 3111 can be formed of asofter plastic material that will flex as the protruding collar of theinner lid 3112 rotates against it. This flexing can create a seal aroundthe hole 3115. When the inner lid 3112 is rotated such that a hole 3115aligns with a port 3102, the collar can “snap” into position as italigns with the port 3102. In some embodiments, each hole 3115 can havean insert formed of a sealing material such as rubber to form a sealbetween inner lid 3112 and outer lid 3111 to prevent fluids or gasesfrom escaping from the hole 3115.

FIGS. 33A-33D illustrate views of a tissue treatment system 3300including a tube management device 3310 in accordance with variousembodiments of the present disclosure. The tube management device 3310can include a plurality of tube restriction devices in the form ofpress-down buttons 3315 that block or unblock the correct tubing lines3316 when pressed. In some embodiments, each press-down button 3315 caninclude an annotation 3311 that corresponds to a step in the tissueprocessing procedure. Example annotations 3311 include “liposuction,”“rinse,” “mix,” “drain,” or “extract.” In some embodiments, theannotations 3311 can include a numeral that indicates the placement ofthe corresponding step in the sequential order of steps that form theprocedure.

In some embodiments, when a press-down button 3315 is pressed down andlocked, the appropriate tubes 3316 are pinched off while other tubingpaths are left open. For example and as shown in the isolated view ofthe press-down buttons 3315 in FIG. 33A, each press-down button 3315 caninclude one or more cutouts 3320 shaped to allow tubes that passtherethrough to remain unblocked when the button is pressed. In theexample shown, four tubes 3316 can pass below the button 3315 labeled“2. Rinse” and the button labeled “1. Liposuction”. When the button 3315labeled “2. Rinse” is pressed, the two innermost tubes are not blockedwhile the two outermost tubes 3316 are blocked. When the button 3315labeled “1. Liposuction” is pressed, the two innermost tubes 3316 areblocked while the two outermost tubes 3316 are not blocked.

FIG. 34 illustrates a tissue treatment system 3400 including analternative tube management device including a plurality of tuberestriction devices in the form of snap-down panels 3410. The snap-downpanels 3410 can clamp the appropriate tubes 3402 for each step in atissue processing sequence in a manner similar to a pinch valve. Forexample, the underside of each snap-down panel 3410 can include a seriesof cutouts in similar fashion to the cutouts described above withreference to the press-down buttons 3315 of FIGS. 33A-33D. In someembodiments, each snap-down panel 3410 can include a hinged end 3410 aand a grip end 3410 b. The user can grasp the grip end 3410 b to applydownward force to the snap-down panel 3410 to lock it into place. Assuch, the grip end 3410 b can include a latch that engages with the bodyof the system 3400 to hold the panel in a locked-down position. Inaccordance with various embodiments, each snap-down panel 3410 caninclude an annotation 3411 that corresponds to a step in a tissueprocessing sequence. The user can thus be directed to perform steps insequence by ordering activation of the snap-down panels in a progressionfrom first step to last.

FIG. 35 illustrates a tissue treatment system 3600 with an outlet 3610to extract adipose tissue in accordance with various embodiments of thepresent disclosure. The outlet 3510 can pass through the center of ashaft 3512 where the mixing blades 3513 are mounted. In someembodiments, placing the outlet 3510 in fluid communication with thebottom of the filtering structure 3515 via the shaft 3512 allowsefficient withdrawal of tissue without the need to tip the system 3600to one side or the other. In some embodiments, the outlet 3610 can passthrough a portion of the rotary handle 3521 as shown in FIG. 36. In someembodiments, the outlet 3610 can be shaped and sized to mate with asyringe.

FIGS. 37A and 37B illustrate views of a tissue treatment system 3700with a low profile in accordance with various embodiments of the presentdisclosure. In some embodiments, a width 3730 of the system 3700 can begreater than a height 3735 of the system 3700. For example, the width3730 can be greater than at least two times, three times, four times, ora higher multiple of the height 3735 of the system 3700. The low profilecreated by having a greater width 3730 than height 3735 can improvestability and prevent translation or tipping of the system during mixingand extraction operations by lowering the center of gravity of thesystem 3700 in some embodiments.

FIG. 38 illustrates a tissue treatment system 3800 with an ergonomicrotary handle 3821 in accordance with various embodiments. The gripportion 3822 of the rotary handle 3821 can be formed in a variety ofshapes and sizes to fit the hand of a user. For example, the gripportion 3822 can have a flattened geometry (e.g., ellipsoidal ratherthan circular) to provide a more comfortable grip. In an exemplaryembodiment, the grip portion 3822 can freely rotate atop a cross piece3825. A rotating grip portion 3822 can allow the user to grasp the gripportion 3822 and maintain the same grasping posture without needing toreadjust throughout a complete rotation of the rotary handle 3821. Insome embodiments, the rotary handle 3821 can include a raised platform3824 where the base of the rotary handle 3821 meets the system 3800. Theraised platform 3824 can provide additional clearance between the rotaryhandle 3821 and the top of the system 3800 to prevent the user fromhitting part of the hand (e.g., knuckles) on the system 3800 whileoperating the handle 3821.

FIGS. 39A and 39B illustrate a tissue treatment system 3900 including asupport handle 3930. In accordance with various embodiments, the usercan grip the support handle 3930 to transport the system 3900 orimmobilize the system 3900 during a tissue processing operation. In someembodiments, a base end 3930 a of the support handle 3930 can be at asame level as the base of the system 3900 as shown in FIG. 39B. In otherwords, the base end 3930 a and the base of the system 3900 can both makecontact with a flat surface when the system 3900 is placed on thesurface. As a result, the base end 3930 a of the support handle 3930 canprovide an additional point of contact between the system and thesurface upon which it rests. The additional point of contact increasesstability of the system and can prevent tipping similar to the functionof an outrigger on a sailing vessel. In some embodiments, the supporthandle 3930 is formed by molding.

FIG. 40 illustrates the tissue treatment system 3900 with a plurality ofsupport handles 3930. The plurality of support handles 3930 can act likea tripod to provide increased stability in some embodiments. The use ofa plurality of support handles may also provide a variety of hand grippositions and/or allow multiple persons located on opposite sides of thesystem 3900 to perform steps in the tissue processing procedure withoutneeding to rotate the entire system to face each person in turn.

FIGS. 41A-41C illustrate a tissue treatment system 4100 and associatedpackaging 4160 in accordance with various embodiments of the presentdisclosure. In accordance with various embodiments, the tissue treatmentsystem 4100 can be placed into the packaging 4160 to stabilize thesystem. In some embodiments, the packaging 4160 can be vacuum formed tosnugly fit a container of the system 4100 within. The packaging 4160 canprovide cushioning and protect the system 4100 during shipping ordelivery of the product. Upon receipt by the customer, the packaging4160 and system 4100 can be removed from the shipping container andassembled together. For example, the system 4100 can be shipped withinthe packaging 4160. To remove the system 4100 from the packaging 4160 insome embodiments, a seal cover 4161 can be peeled back to reveal thesystem 4100. In some embodiments, the system 4100 can be removed fromthe packaging 4160, inverted, and placed back into the packaging 4160.The packaging 4160 can have a wide base to prevent tipping and stabilizethe system 4100 during use. In some embodiments, the packaging 4160 caninclude molded grooves 4134. The molded grooves 4134 can help to managethe tubing by routing the tubing down towards the base of the packaging4160.

FIGS. 42A and 42B illustrate a mounting system 4205 and a tissuetreatment system 4200 including the mounting system 4205, respectively,in accordance with various embodiments of the present disclosure. Themounting system 4205 can include a variety of structures that can securethe treatment system 4200 to a surface to increase stability duringvigorous steps of a tissue processing procedure such as operating themixing blades. In some embodiments, the mounting system 4205 can includehook-and-latch structures or suction cups. The mounting system 4205 canbe affixed to the underside of the treatment system 4200 using adhesive,screws, or other appropriate means for attachment. In some embodiments,the mounting system 4205 can prevent the tissue treatment system 4200from sliding or translating on the surface to which it is attached.

FIG. 43 illustrates a tissue treatment system 4300 including a mountingsystem 4350 in accordance with various embodiments of the presentdisclosure. In accordance with various embodiments, the mounting system4350 can be provided separately and can be attached or detached from thetissue treatment system 4300 and a mounting surface in the environment.In some embodiments, the mounting system 4350 can include a clip 4355 toattach the mounting system to a surface in the environment. The clip4355 can be spring loaded. In some embodiments, the clip 4355 can beadapted to secure the mounting system 4350 to an edge of a Mayo stand.In accordance with various embodiments, the mounting system 4350 caninclude a depression 4359 that mates with features 4309 havingcomplementary shapes on the tissue treatment system 4300. The features4309 can include protruding or recessed structures 4308 that interactwith corresponding structures within the depression 4359. For example,the protruding structures 4308 can include a ridge or other snap fitfeature that interacts with a ridge or recess in the depression tocreate an interlock that holds the system 4300 in place.

FIGS. 44A and 44B illustrate a tissue treatment system 4400 including abase 4450 to store a fluid bag 4451 in accordance with variousembodiments of the present disclosure. The system 4400 can include atissue treatment device 4402 attached to a flat base 4401 that islowered onto the fluid bag 4451 in the base 4450. In some embodiments,the flat base 4401 is undersized compared to the dimensions of the base4450 such that the flat base 4401 can pass into the base 4450 fromabove. According to various embodiments of the present disclosure, thefluid bag 4451 can include a variety of fluids relevant to tissueprocessing including water, Ringer's solution, or a rinse solution. Inmany embodiments, the weight of the liquid in the fluid bag 4451provides additional stability to the system 4400. When assembled, a hole4452 in the base 4250 can allow a tube to pass through from the fluidbag 4451 to the treatment device 4402. In some embodiments, the user canapply downward force to the flat base 4401 to “pump” fluid from thefluid bag 4451 into the tissue treatment device 4402.

FIGS. 45A and 45B illustrate a tissue treatment system 4500 includingbase 4550 for storage of a fluid bag 4551 in accordance with variousembodiments of the present disclosure. In some embodiments, the fluidbag 4551 can act as a weight to increase stability of the system 4500and prevent tipping or sliding of the system 4500. In some embodiments,the system 4500 can include a bag spike 4520 to both pierce the fluidbag 4551 and convey the fluid from the fluid bag 4551 into the mixingunit 4502. The bag spike 4520 can include a stopcock 4521 in someembodiments to open or close the flow of fluid from the fluid bag 4551in some embodiments. The bag spike 4520 can include an elbow joint orbend in some embodiments. In some embodiments, the system 4500 caninclude a cover 4504 that can be closed over the fluid bag 4551 toprovide protection and prevent accidental puncture of the fluid bag4551.

FIGS. 46A and 46B illustrate perspective and side views, respectively,of a tissue treatment system 4600 in accordance with various embodimentsof the present disclosure. The system 4600 can include a wide base 4630to provide increased stability for the system 4600 during steps of atissue treatment procedure. In an exemplary embodiment, tubes 4602 a-ccan pass into the wide base 4630 and exit from system 4600 through thewide base 4630. By passing the tubes 4602 a-c into the wide base 4630,the tubes are well-secured and stay out of the user's way during stepsof the surgical procedure. In some embodiments, access to the system4600 through each tube 4602 a-c can be regulated using a valve 4612.Exemplary valves 4612 can include two-way (i.e., on/off) valves orthree-way (i.e., tube 1, tube 2, off) valves. For example, a three-wayvalve can be used to control the patient tube 4602 b to switch betweenliposuction (e.g., patient tissue extraction), Ringer's solution, or allclosed. In some embodiments, the patient tube 4602 b can connect to aT-connector to split the connection. In some embodiments, the extractiontube 4602 c can be connected to the bottom of a filtering structure toenable extraction of the processed tissue. In some embodiments, a vacuumcan be applied to the vacuum tube 4602 a to remove waste. In someembodiments, the system 4600 can include a rotating dial 4608 to controlvent access to the system 4600.

FIG. 47 illustrates a tissue treatment system 4700 with a wash cyclecounter 4710 in accordance with various embodiments of the presentdisclosure. The wash cycle counter 4710 can notify a user of the numberof wash cycles that have been performed. In some embodiments, the washcycle counter 4810 can engage a mechanism after a specified number ofwash cycles have been completed. The mechanism, which can include abrake, can prevent the mixing handle from turning after the specifiednumber of wash cycles has been achieved. In various embodiments, thenumber of washes indicated by the wash cycle counter 4810 can beadvanced manually by the user or can be advanced based upon the numberof turns made by the mixing handle.

FIGS. 48A and 48B illustrate a collapsible tissue treatment system 4800in uncollapsed and collapsed states, respectively, in accordance withvarious embodiments of the present disclosure. The collapsible tissuetreatment system 4800 can include a top plate 4803 and a bottom plate4804 with a foldable exterior wall 4801 extending therebetween. Withinthe foldable exterior wall 4801, the system 4800 can include acollapsible filtering structure 4715 and a collapsible mixing shaft 4812connected to mixing blades. In an uncollapsed state, arms 4805 extendingbetween the top plate 4803 and the bottom plate 4804 can hold the platesseparated. In some embodiments, the arms 4805 can connect to the topplate 4803 or the bottom plate 4804 using clamps 4806 or other suitablefastening systems. The system 4800 in the uncollapsed state can be usedto perform processing and washing steps of a tissue processingprocedure.

In accordance with various embodiments, when the tissue has beenadequately washed, the collapsible tissue treatment system 4800 can becollapsed similar to an accordion to force tissue towards an extractionport 4811. In some embodiments, the clamps 4806 of the arms 4805 can bedisengaged from the top plate 4803 or bottom plate 4804 and can swingaway. The top plate 4803 can then be urged toward the bottom plate 4804to reduce a volume within the foldable exterior wall 4801.

The collapsible filtering structure 4815 can include a mesh or otherunstructured filtering element lacking reinforcement in someembodiments. The collapsible mixing shaft 4812 can comprise segments insome embodiments wherein the segments slide into one another from bottomto top or top to bottom. The segments can have a flared shape to prevententry of fluids between segments when the mixing shaft 4812 is in theextended position.

FIGS. 49A-49C illustrate a tissue treatment system 4900 in accordancewith various embodiments of the present disclosure. In accordance withvarious embodiments, the tissue treatment system 4900 can include anouter cover 4901 enclosing a mesh filter 4915. The tissue treatmentsystem 4900 can include an attachment feature 4970 to hang or suspendthe system 4900 in the vicinity of the patient. The tissue treatmentsystem 4900 can allow agitation, mixing, and extraction of tissue fromthe device by hand and without the use of mixing blades as shown in FIG.49B.

In some embodiments, the outer cover 4901 can be made of a leakresistant but flexible material such as rubber. As illustrated, severalports 4902 (i.e., liposuction port, vacuum port, rinse port, extractionport) can extend through the outer cover 4901. Some ports 4902 (e.g.,the rinse port, liposuction port, and extraction port) can furtherextend to the interior of the mesh filter 4915. The tube connected toeach port 4902 can be clamped or unclamped to allow or prevent flow intothe port 4902, respectively.

The attachment feature 4970 can enable the system 4900 to be placed at aconvenient location within the surgical space. For example, surfacespace is often limited in the operating room to allow surgeons freedomof movement near the patient. The attachment feature 4970 can allow thesystem to be attached to any object in the operating room such as apatient gown, surgical drape, Mayo stand, or IV stand. In someembodiments, the attachment feature 4970 can include a loop to allowsuspension of the system from the loops of the IV pole as shown in FIG.49C. In some embodiments, the attachment feature 4970 can include a clipor clamp that can be attached to a drape or clothing.

FIG. 50 illustrates strain relief for a tube connected to a port in atissue treatment system in accordance with various embodiments of thepresent disclosure. In some embodiments, the ports 5002 can be coveredby a flexible tubing connector 5003 to ease strain on the connectionbetween the port and the tube. The tubing connector 5003 can be made ofa soft material in some embodiments. The tubing connector 5003 can helpprevent the system from being jostled too harshly during manipulationand movement of the tubes and/or during the tissue processing procedure.

FIG. 51A-51C illustrate views of a tissue treatment system 5100 inaccordance with various embodiments of the present disclosure. Thetissue treatment system can include ports 5102, mixing blades 5130, amulti-position switch 5106, and a handle 5104 to operate the mixingblades 5130. In accordance with various embodiments, the handle 5104 canrotate about an axis 5110 that is tilted with respect to the axis of ashaft connected to the mixing blades. In alternative embodiments, thehandle 5104 can rotate about an axis that is parallel to the shaftconnected to the mixing blades and tilted with respect to the surfacenormal of the bottom of the device. In some embodiments, themulti-position switch 5106 can step the user through the steps of thetissue processing procedure and open and close the corresponding portconnections for each step as described above with reference to earlierfigures. A transfer port 5160 can exit from the front of the device.

FIG. 52A-52C illustrate views of a tissue treatment system 5200 inaccordance with various embodiments of the present disclosure. Thesystem 5200 can include ports 5102, handle 5104, mixing blades 5130, andmulti-position switch 5106 as described above with reference to FIG.51A. In accordance with various embodiments, the transfer port 5260 canextend out of a top surface of the system 5200 and connect internally toa tube that passes to the bottom of the device. The system 5200 caninclude a gripping surface 5220 in some embodiments that allows the userto better stabilize the system 5200 during tissue processing.

FIG. 53A-53C illustrate views of a tissue treatment system 5300 inaccordance with various embodiments of the present disclosure. Thetissue treatment system can include ports 5302, mixing blades 5330, amulti-position switch 5306, and a handle 5304 to operate the mixingblades 5330. In some embodiments, the bulk of the handle 5304 can beflush with a top surface of the system 5300 to provide a low profile. Insome embodiments, the multi-position switch 5306 can include arotational dial that is flush with the outer surface of the system 5300.The rotational dial can step the user through the steps of a tissueprocessing procedure and open and close corresponding connections foreach step. In some embodiments, the system 5300 can include a grip area5320 to allow the user to better stabilize the system 5200 during tissueprocessing.

FIG. 54A-54E illustrate views of a tissue treatment system 5400 inaccordance with various embodiments of the present disclosure. In someembodiments, the tissue treatment system can include a flip-out handle5404. The flip-out handle 5404 can be flipped out to a first position toprovide a rotating handle grippable by a user to move the mixing blades.When the flip-out handle 5404 is not in use, it can be flipped in andrested in a second position in a groove 5405 on a top surface of thesystem 5400. In the flipped-in position, the flip-out handle 5404 isstowed away where it will not be bumped during further processing steps.In addition, immobilization of the flip-out handle 5404 will preventaccidental manipulation of the mixing blades at points in the procedurewhere such motion is not desirable.

While the present invention has been described herein in conjunctionwith preferred embodiments, a person of ordinary skill in the art caneffect changes, substitutions or equivalents to the systems and methodsdescribed herein, which are intended to fall within the appended claimsand any equivalents thereof.

1. A tissue treatment system, comprising: a container, including: anexterior wall surrounding an interior volume for holding tissue; and afiltering structure for processing tissue.
 2. The tissue treatmentsystem of claims 1, further comprising an extraction port in fluidcommunication with the interior volume.
 3. The tissue treatment systemof claim 1, further comprising a plurality of ports, each port in fluidcommunication with the interior volume.
 4. The tissue treatment systemof claim 1, further comprising a turbine to turn a mixing shaftincluding mixing blades or paddles.
 5. The tissue treatment system ofclaim 4, wherein the turbine has an air intake and an air outlet andturns upon application of negative pressure to the air outlet.
 6. Thetissue treatment system of claim 1, further comprising a spring andneedle gauge to indicate the mass of tissue present within the interiorvolume of the system.
 7. The tissue treatment system of claim 1, whereinthe filtering structure is formed of a single piece of material that isfolded and sealed along an edge.
 8. The tissue treatment system of claim1, further comprising a telescoping mixing paddle having at least oneblade at a first axial position and at least one blade at a second axialposition different than the first axial position.
 9. The tissuetreatment system of claim 8, wherein the blades at different axialpositions can rotate with respect to one another.
 10. The tissuetreatment system of claim 8, wherein the telescoping mixing paddle isconvertible to a piston form.
 11. The tissue treatment system of claim1, further comprising a mixing and auger system including a centralshaft having at least one mixing blade and an auger.
 12. The tissuetreatment system of claim 1, further comprising a motorized system toautomatedly rotate at least one mixing blade including a battery-poweredmotor or a spring-loaded wind-up mechanism.
 13. The tissue treatmentsystem of claim 1, further comprising a base unit into which thecontainer is inserted and including a rotating handle mechanism and atop cover.
 14. The tissue treatment system of claim 1, furthercomprising an inner lid including a plurality of holes and an outer lidincluding a plurality of ports, the inner lid being rotatable relativeto the outer lid.
 15. The tissue treatment system of claim 1, furthercomprising a plurality of tube-restriction devices.
 16. The tissuetreatment system of claim 15, wherein the plurality of tube-restrictiondevices comprises press-down buttons.
 17. The tissue treatment system ofclaim 15, wherein the plurality of tube-restriction devices comprisessnap-down panels.
 18. The tissue treatment system of claim 1, furthercomprising a base connected to the container for storage of a fluid bag.19. The tissue treatment system of claim 1, further comprising a topplate, a bottom plate, and a plurality of arms, the exterior wallconnecting the top plate and bottom plate and being foldable, whereinthe filtering structure is collapsible, and wherein the plurality ofarms holds separated the top plate and bottom plate while the system isin an uncollapsed state.
 20. The tissue treatment system of claim 1,further comprising a flip-out handle that is rotatable in a firstposition and rests in a groove in a second position.